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Location: Bulgaria; Croatia; Poland; Romania; Greece Join our global Pharmacovigilance team as a Pharmacovigilance Specialist (Medical/Clinical Safety). Pharmacovigilance Specialist (Medical/Clinical Safety) is responsible for assuring compliance with the Quality Management System. Participating in the collection, safety review, processing and reporting of safety information in compliance with applicable global and local regulations and Biomapas standard operating procedures and guidelines. Position is in any EU country. Responsibilities: Responsible for processing of ICSRs, Serious Adverse Event (SAE) from Clinical trials (safety database entry, tracking, narrative writing, requesting follow-up from site, quality checks/review and reporting to client (s) or agencies for assigned projects) Perform reconciliation of safety data Participate in Project / Study Team meetings as the Safety and Pharmacovigilance representative Oversee the planning, coordination, and quality review of aggregate safety reports, support the preparation and submission of regulatory safety documents (e.g., DSURs, 6MLL). Supervision of local handling, including preparation and submission, of Periodic Safety Update Reports, Risk Management Plans and risk minimization activities Collaborate with medical, safety physicians, and data management, IT, other functions to ensure timely and accurate reporting or reports delivery Act as Biomapas and/or contractual partners 24/7 local contact person or back up for pharmacovigilance at local level Ensure the survey and monitoring of national / regional pharmacovigilance regulations Collection and processing of any medical enquiry/inquiry/answer received via phone/e-mail/fax or by other means from any source Support of weekly monitoring of local or global literature review Support of continuous safety profile monitoring, detection of new signals and evaluation Participate in related inspection and/or audits, including post inspection/audit support, when required Requirements University degree in the Life Science field At least 4+-years’ experience in Pharmacovigilance, clinical safety and clinical development and expert knowledge of pharmacovigilance legislation Knowledge of international regulations (ICH, EU GVP Modules, FDA) Experience working with PV databases (e.g., Argus, ArisG) and MedDRA coding Ability to interpret and apply global drug safety regulations Fluent English and local country language Eager to adopt automations and new technologies in daily tasks Attention to detail, time-management and problem-solving skills Project management experience is beneficial Benefits Professional growth and career opportunities International team and environment Bonus based on annual performance Personal accident and business trip insurance Additional health insurance Remote/home based Rewarding referral policy Workplace establishment allowance (fully remote) Team building, global meetings

Location: Turkey Delta PV, a leading pharmacovigilance service provider headquartered in Istanbul, Türkiye, has been part of the Biomapas group since 1 August 2025. As such, this vacancy is advertised on behalf of Delta PV within the Biomapas organization. Pharmacovigilance Specialist is responsible for operational delivery for assigned tasks on the project level. Pharmacovigilance Specialist can act as the Primary or Secondary Project Responsible for the project assigned. Pharmacovigilance Specialist is communicating to Pharmacovigilance Team Leader/ Pharmacovigilance Manager about potential risk related to operational delivery, quality, client relationship and company reputation, as well as ad hoc project tasks and project requirements. Pharmacovigilance Specialist can be engaged in company’s procedures review and update. Responsibilities Performing tasks based on weekly work planning meetings. Performing tasks in cooperation with the Pharmacovigilance Managers and Team Leaders according to a specified plan. Supporting weekly/monthly local and global literature screening. Translation of adverse events and quality complaints from Turkish to English. Entering cases into database system and generating their formal reports. Supporting follow-up of safety alerts. Ensuring that reconciliation process is in place and performed regularly with clients. Ensuring continuity of PV activities in the absence of a Pharmacovigilance Specialist. Following the principles of data integrity, confidentiality and personal data protection, as applicable. Continuously developing his/her professional and personal skills and participating in pharmacovigilance relevant trainings. Requirements A Pharmacy degree (Mandatory). Excellent written and oral communication skills in English and Turkish (MANDATORY). At least 1 year PV experience. Experience in pharmaceutical companies is an advantage. Exposure to healthcare/life-sciences industry is an advantage. Benefits Professional growth and career opportunities International team and environment Health & Life Insurance Monthly Food Allowance Monthly Transportation Fee Remote Work

Location: Remote, Worldwide; Remote - Europe Workplace: remote About Welo Life Sciences  Welo Life Sciences, a Welo Global brand, is a specialized language and technology partner serving pharmaceutical, CRO, and medical device organizations operating in regulated global markets. We deliver regulator-ready translation, linguistic validation, and localization solutions that support clinical trials, pharmacovigilance, regulatory affairs, labeling, and global commercialization. Our approach combines subject matter expertise with ISO-certified quality processes and technology-enabled workflows designed to integrate seamlessly into life sciences operations. With extensive experience supporting global product development and post-market requirements, Welo Life Sciences helps organizations accelerate timelines, protect data integrity, and maintain compliance across languages and regions. All solutions are delivered within a secure, audit-ready framework supported by seven ISO certifications.  welolifesciences.com About the Role We are looking for experienced Spanish (Spain) to English (GB or US) linguists to support a high-volume, fast-turnaround pharmacovigilance program for a leading global pharmaceutical company. Work involves translating and reviewing safety and regulatory content, including adverse event reports and related clinical documentation, with strict turnaround times and deadlines.  This is an ongoing freelance engagement with daily volumes. Key Responsibilities Translate Pharmacovigilance and/or Clinical-regulatory content from Spanish into English. Perform Machine Translation Post-Editing (MTPE) on machine-translated safety content. Perform Copy Edit review of translated/post-edited content for accuracy, tone, and consistency. Meet strict, non-extendable turnaround times on time-sensitive safety content. Requirements Degree in translation, linguistics or languages studies or an equivalent degree that includes significant  translation training. Minimum 2 years of professional experience translating medical documentation, specificially with experience and knowledge in Pharmacovigilance and/or Clinical-Regulatory content. Experience translating pharmacovigilance content preferred: SAE/AE (serious and non-serious adverse events), PSURs, SUSARs, ICSRs, DSURs, Risk Management Plans (RMP). Alternatively, experience translating regulatory or clinical documents: medical reports, protocols, synopses, ICF, discharge reports, study reports, SmPC, PIL, or medical literature. Great daily availability: this program requires consistent daily capacity and is not suited to part-time schedules. Strong Spanish proficiency; native level of English preferred but not mandatory. Experience with XTM or similar CAT tools. Reliable, deadline-driven, and flexible, able to commit to fast turnaround times with no extensions. Nice to Have Healthcare professional (HCP) background: nurse or physician preferred, especially with emergency room experience. Other HCP backgrounds also welcome. Willingness to commit to daily and/or weekend availability. Tools & Systems CAT tool: XTM, client-provided license; onboarding and connector setup provided after onboarding.   Job Reference: #LI-JC1

Responsible for reviewing adverse events and assisting in the determination of regulatory reporting for assigned investigational products. May serve as a liaison to internal and external stakeholders for AE reporting issues (i.e. site staff, CRAs, case processing vendor). Works in collaboration with other functional groups such as data management, clinical operations, regulatory affairs, quality, and medical affairs.

Location: Croatia; Bulgaria; Poland; Czechia; Slovakia; Greece Join our global Pharmacovigilance team as a Sr. Pharmacovigilance Specialist. Senior Pharmacovigilance Specialist is responsible for supporting global and local PV systems and ensuring compliance with all PV activities with international or local regulations. May overtake additional regional or local PV responsible person roles for simple PV systems. The position is remote, home-based in any EU country. All CVs must be submitted in the English language for consideration. Responsibilities: Act as the Project Manager or deputy Project Manager for the assigned projects Perform accurate forecasting and contribute to budget planning, ensuring efficient functioning of the QPPV Office Update SOPs and act as a subject matter expert for PV in assigned company processes Maintain KPI reports and perform core and standard PV activities for assigned contractual partners. Manage Full or local Pharmacovigilance systems and projects (or part of them) and/or central pharmacovigilance activities (e.g. end-to-end case processing, Aggregate Safety Reports, Risk Management Plans and risk minimization activities) in both pre- and post-authorization setting (as applicable) Act as a customer contact point (where applicable), ensuring consistent communication and escalation management across assigned projects Act as the appointed EU QPPV or deputy EU QPPV in accordance with a separate QPPV Job Description (if applicable) Ensure high-quality performance of PV services in assigned region/country and timely communication with Health Authorities Ensure inspection/audit readiness and finding remediation Requirements Biologist, Pharmacist, Medical Doctor, or other life science degree 4-year experience in global Pharmacovigilance activities Fluent English Computer literacy (MS Office), experience with PV databases (Veeva Vault Safety experience is an advantage) Strong organizational and time management skills Ability to work independently and in a team Strong organization, prioritization, and time management with reliable delivery of commitments Strong communication and relationship building skills across functional teams Benefits Professional growth and career opportunities International team and environment Bonus based on annual performance Personal accident and business trip insurance Additional health insurance Remote/home based Rewarding referral policy Workplace establishment allowance (fully remote) Team building, global meetings

Location: Poland; Czechia; Italy (Senior) Director Pharmacovigilance Operations /Central PV Services is responsible for the leadership, strategic development, and operational oversight of the global Central Pharmacovigilance (PV) Services organization. The role ensures compliant, efficient, and scalable delivery of centralized pharmacovigilance services, including Individual Case Safety Report (ICSR) processing, literature surveillance, signal detection and management, benefit-risk management, aggregate safety reporting, and related PV operational services. The role is accountable for building and expanding strategic global delivery hubs, developing scalable outsourcing models, driving operational excellence, and supporting the operational, financial, and client objectives of the PV & MI Business Unit. This is remote role for anyone within European Union. Key areas of responsibility and main tasks: Strategic & Functional Leadership Execute the Central PV Services strategy in alignment with the PV & MI Business Unit objectives. Develop scalable centralized PV operating models supporting global clinical development and post-marketing programs. Lead establishment, expansion and optimization of global PV delivery hubs. Develop strategic outsourcing models to improve scalability, quality, operational efficiency, and financial performance. Drive innovation, automation, AI-enabled technologies and digital transformation across Central PV Services. Advise the VP, Global Safety & MI on operational strategy, service delivery, capacity planning and operational risks. Act as escalation point for significant Central PV operational and service delivery issues. Provide operational performance reporting, delivery metrics and strategic updates to senior management. Central PV Operations & Delivery Excellence Provide strategic and operational oversight of centralized pharmacovigilance services across: Case Management (ICSR processing, case intake and triage, medical coding, quality review, and medical review support). Literature Management (literature surveillance, screening, and literature case processing). Signal & Benefit-Risk Management (signal detection, validation, evaluation, benefit-risk assessment, and related risk management activities). Aggregate Safety Reporting (PSURs/PBRERs, DSURs, PADERs, and other regulatory aggregate safety reports). Operational Excellence (Safety Data Exchange activities, operational metrics and reporting, process standardization, automation, continuous improvement, and service delivery governance). Ensure all Central PV Services are delivered in accordance with applicable regulations, contractual obligations, internal procedures, quality standards, and client expectations. Monitor operational, quality, and productivity KPIs, ensuring timely escalation, corrective actions, and continuous improvement initiatives. Drive operational excellence through standardized processes, technology enablement, automation, and scalable delivery models that support sustainable business growth. Global Delivery Hub & Outsourcing Strategy Develop and implement the global strategy for centralized PV delivery, ensuring scalable, efficient, and consistent service delivery across regions. Build, expand, and optimize strategic centralized PV delivery hubs to support business growth and evolving client needs. Lead the transition and integration of PV activities into centralized delivery models, ensuring effective governance, business continuity, and operational consistency. Establish standardized operating models, resource planning, and workforce strategies to optimize capacity, utilization, and delivery performance across global operations. Drive continuous improvement through process optimization, innovation, digital solutions, and enabling technologies to enhance quality, efficiency, and scalability. Develop and maintain resilient global delivery capabilities that support sustainable growth, client satisfaction, and high-quality service delivery. Compliance & Operational Quality Maintain inspection-ready Central PV operational processes. Ensure delivery complies with EU GVP Modules, FDA, ICH and other applicable global regulations. Support regulatory inspections and client audits involving Central PV Services. Oversee implementation and follow-up of CAPAs related to operational activities. Ensure governance of operational KPIs, quality metrics and compliance monitoring. Collaborate with QPPV Office, Medical/Clinical Safety, PV/MI Technologies, and Medical Information functions to ensure harmonized PV/MI governance. Financial & Business Support Contribute to Business Unit financial targets through effective operational planning, workforce optimization and resource forecasting. Support pricing, proposals, RFIs, RFPs and bid defenses by providing operational expertise, delivery models and resource assumptions. Identify opportunities for operational efficiencies, automation and cost optimization while maintaining quality and compliance. Support expansion of Central PV Services across existing and new clients. Team Management Lead and develop the Central PV Services leadership team. Build organizational capability supporting global service expansion. Drive succession planning and talent development. Promote a culture of operational excellence, accountability, innovation and continuous improvement. Ensure appropriate organizational structures supporting sustainable growth. Client & Cross-Functional Collaboration Support client retention through high-quality operational delivery and continuous service improvement. Partner closely with the QPPV Office, Program Management, Operations Strategy, PV/MI Technologies, Medical & Clinical Safety and Medical Information to ensure integrated service delivery. Collaborate with Quality, Regulatory, Commercial, Legal and Business Development functions. Represent Central PV Services during governance meetings, operational reviews and client engagements. Support strategic client initiatives involving centralized PV outsourcing and transformation Other responsibilities Identify areas for improvement and proactively propose solutions within the area of responsibility. Deputize for another employee or staff member of the same department as instructed by the Head of Department. Perform additional tasks related to the department's activities as assigned by the Head of Department Requirements MD, PharmD, PhD, MSc or equivalent scientific degree preferred. At least 12 years of pharmacovigilance experience. At least 5 years of progressive leadership experience managing global PV operations. Demonstrated experience leading centralized PV services and global delivery organizations. Extensive knowledge of case processing, literature surveillance, signal detection, benefit-risk management and aggregate reporting. Experience building global shared service centers and scalable outsourcing models. Strong knowledge of EU GVP Modules, ICH guidelines, FDA and global PV regulations. Experience supporting regulatory inspections and client audits. Strong understanding of safety databases and PV technologies. Demonstrate strong leadership and collaboration by effectively leading and aligning global operational teams. Drive executive communication through operational excellence and strategic execution. Influence stakeholders across complex global organizations. Demonstrate strategic thinking with a strong operational excellence mindset. Apply advanced decision-making and problem-solving skills. Demonstrate negotiation skills and commercial acumen with a client-focused approach. Stay informed of emerging PV technologies, automation, AI, and regulatory developments. Effectively adapt to and lead organizational change. Apply coaching and mentoring techniques to develop future leaders. Demonstrate behaviors aligned with Company values, cultural awareness, and the ability to work effectively in diverse environments. Professional level in English, both oral and written. Benefits International team and environment Remote Work, workation & Flexibility Health & Wellbeing – wellness initiatives Professional growth and development in the Life science industry Team Culture – Team buildings and global meetings. Performance based annual bonus Comprehensive Insurance - Personal accident, business trip coverage, and additional health insurance.

Location: Poland; Finland; Australia; South Africa; Germany; Estonia We’re building a local network of talented PV experts to collaborate with on future projects. We’d love to connect with professionals who are interested in staying in touch for freelance (parttime) opportunities. Let’s start the conversation and build a connection! Currently we are looking to add people to our network in Poland. At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of post-marketing regulatory requirements to ensure continued safety and availability of life-changing therapies for patients around the world. At Allucent we are big enough to deliver and small enough to care. We know all our colleagues by name and work together as a team to make everyone SHINE. The role The Local Contact Person for Pharmacovigilance (LCPPV) coordinates and performs the logistical aspects of pharmacovigilance activities in post-marketed programs to ensure compliance with local requirements. This position controls and monitors operational pharmacovigilance activities and may back-up Pharmacovigilance Manager(s) as required. Main responsibilities: Acts as the primary point of contact for the local regulatory authorities, including 24/7 if legally required Monitors and maintains awareness of safety issues and recommendations published by the local regulatory authorities, concerning the client products or products class Monitors and maintains awareness of changes to local legislation pertaining to pharmacovigilance Supports client audits and inspections, as required, including attendance, provision of requested documentation and completion of Corrective Actions and Preventive Actions (CAPAs), if needed Performs local literature screening and collection of safety information Assists on the development or the review of the local pharmacovigilance system master file (LPSMF), if required Supports local signal detection, if applicable Manages locally risk minimization measures, as applicable Reports to and maintains regular communication with the EU QPPV Supports the review of local PV agreements, if requested Performs local PV training to eg. sales force, affiliate personnel, distributors Provides monthly activity report on status of local PV system Requirements Who are we looking for: University degree, preferably in medicine, pharmacy or life sciences and minimum 2 years of experience in the performance of pharmacovigilance post-marketing activities Have up-to-date knowledge of applicable global and local regulatory requirements In-depth knowledge of the pharmacovigilance legal framework in country where LCPPV services are delivered Fluency in the written and spoken English language Reside in the country where LCPPV provides services, if required Benefits About Allucent Our mission is to help bring new therapies to light. When you work at Allucent, that means applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments. If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow. Together we SHINE. Find more information about our values. Disclaimers: “The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

Location: Remote Workplace: remote About Welo Life Sciences  Welo Life Sciences, a Welo Global brand, is a specialized language and technology partner serving pharmaceutical, CRO, and medical device organizations operating in regulated global markets. We deliver regulator-ready translation, linguistic validation, and localization solutions that support clinical trials, pharmacovigilance, regulatory affairs, labeling, and global commercialization. Our approach combines subject matter expertise with ISO-certified quality processes and technology-enabled workflows designed to integrate seamlessly into life sciences operations. With extensive experience supporting global product development and post-market requirements, Welo Life Sciences helps organizations accelerate timelines, protect data integrity, and maintain compliance across languages and regions. All solutions are delivered within a secure, audit-ready framework supported by seven ISO certifications.  welolifesciences.com About the Role We are looking for experienced French (France) to English (GB and US) linguists to support a high-volume, fast-turnaround pharmacovigilance program for a leading global pharmaceutical company. Work involves translating and reviewing safety and regulatory content, including adverse event reports and related clinical documentation, with strict turnaround times and deadlines.  This is an ongoing freelance engagement with daily volumes. Key Responsibilities Translate pharmacovigilance and/or clinical-regulatory content from French into English. Perform Machine Translation Post-Editing (MTPE) on machine-translated safety content. Perform Copy Edit review of translated/post-edited content for accuracy, tone, and consistency. Meet strict, non-extendable turnaround times on time-sensitive safety content. Occasionally support Transcription tasks, retyping scanned or handwritten PDFs into Word for downstream translation (requires a personal Gmail account for client platform access). Work within the client's CAT tool environment (XTM) following project-specific setup instructions. Requirements Degree in translation, linguistics or languages studies or an equivalent degree that includes significant  translation training. Minimum 2 years of professional experience translating Life Sciences documents. Experience translating pharmacovigilance content preferred: SAE/AE (serious and non-serious adverse events), PSURs, SUSARs, ICSRs, DSURs, Risk Management Plans (RMP). Alternatively, experience translating regulatory or clinical documents: medical reports, protocols, synopses, ICF, discharge reports, study reports, SmPC, PIL, or medical literature. Great daily availability: this program requires consistent daily capacity and is not suited to part-time schedules. Strong French proficiency; native level of English preferred but not mandatory. Experience with XTM or similar CAT tools. Reliable, deadline-driven, and flexible, able to commit to fast turnaround times with no extensions. Nice to Have Healthcare professional (HCP) background: nurse or physician preferred, especially with emergency room experience. Other HCP backgrounds also welcome. Availability to cover US business hours. Willingness to commit to daily and/or weekend availability. Tools & Systems CAT tool: XTM, client-provided license; onboarding and connector setup provided after onboarding. A personal Gmail account is required for linguists supporting Transcription tasks, for access to a client platform.   Job Reference: #LI-JC1

Location: Remote; Canada Workplace: remote About Welo Life Sciences    Welo Life Sciences, a Welo Global brand, is a specialized language and technology partner serving pharmaceutical, CRO, and medical device organizations operating in regulated global markets. We deliver regulator-ready translation, linguistic validation, and localization solutions that support clinical trials, pharmacovigilance, regulatory affairs, labeling, and global commercialization. Our approach combines subject matter expertise with ISO-certified quality processes and technology-enabled workflows designed to integrate seamlessly into life sciences operations. With extensive experience supporting global product development and post-market requirements, Welo Life Sciences helps organizations accelerate timelines, protect data integrity, and maintain compliance across languages and regions. All solutions are delivered within a secure, audit-ready framework supported by seven ISO certifications.  welolifesciences.com We are currently seeking experienced and highly skilled English to Canadian French linguists to join our dynamic Life Sciences program specializing in Pharmacovigilance. This is an exciting opportunity to work on vital medical and clinical content, contributing to global health and safety initiatives. In this role, you will play a critical part in ensuring the accurate and timely delivery of translations under tight deadlines. Many assignments are time-sensitive, requiring quick turnarounds to meet client expectations while maintaining the highest standards of quality. Join our global team and help us make a difference in global health by delivering high-quality translations that support critical medical research and patient safety. Key Details About the Role Translate documents from English (US) to French (Canada) , with a focus on pharmacovigilance content. Perform Translation, Copy Editing (CE), and Machine Translation Post Editing (MTPE) tasks as required, ensuring high-quality standards and consistency. Translate specialized medical and pharmaceutical content, including Product Monographs, Clinical Study Documents, and Medical Information Letters. Adhere to tight deadlines, especially for projects received during EU close-of-business hours, with delivery required for early morning. Work within the client-provided XTM and Phrase (Memsource) CAT tools (licenses will be provided). Maintain professionalism, responsiveness, and reliability to meet client expectations and ensure timely delivery of assignments. Requirements Proven experience in medical and pharmaceutical translation, particularly for pharmaceutical companies or life sciences translation agencies in Quebec or Canada. Specific expertise in translating Product Monographs and Medical Information Letters. Bachelor’s degree in translation or a bachelor’s degree in science (e.g., pharmacology, biology, biochemistry) combined with a translation degree from a Quebec or Canadian university. Membership in a Professional Order (e.g., OTTIAQ) is highly preferred. Fluency in English (source language) and native-level proficiency in French (Canada) (target language). Availability during US time zone business hours (location can be any country). Strong attention to detail, consistency, and commitment to meeting deadlines under time-sensitive conditions. Familiarity with CAT tools, specifically XTM and Phrase (Memsource) (training provided if necessary). Ability to handle sensitive and technical content with confidentiality and precision. Bonus if You Have Experience working with high-volume, time-critical translation projects. Strong background in pharmacovigilance, medical, or pharmaceutical content. Previous experience working in collaborative environments with strict client guidelines. Positive track record of professionalism and reliability in previous roles. Job Reference: #LI-JC1

Location: Remote, Worldwide Workplace: remote About Welo Life Sciences  Welo Life Sciences, a Welo Global brand, is a specialized language and technology partner serving pharmaceutical, CRO, and medical device organizations operating in regulated global markets. We deliver regulator-ready translation, linguistic validation, and localization solutions that support clinical trials, pharmacovigilance, regulatory affairs, labeling, and global commercialization. Our approach combines subject matter expertise with ISO-certified quality processes and technology-enabled workflows designed to integrate seamlessly into life sciences operations. With extensive experience supporting global product development and post-market requirements, Welo Life Sciences helps organizations accelerate timelines, protect data integrity, and maintain compliance across languages and regions. All solutions are delivered within a secure, audit-ready framework supported by seven ISO certifications.  welolifesciences.com About the Role We are looking for experienced English into German linguists specializing in Clinical-trial, Pharmacovigilance and Regulatory document translation. Key Responsibilities Translate clinical research, regulatory and pharmacovigilance documents from English to German. Perform Machine Translation Post-Editing (MTPE) on machine-translated safety content. Perform Copy Edit (translation review) of translated/post-edited content for accuracy, tone, and consistency. Meet strict, non-extendable turnaround times on time-sensitive content. Work within the client's CAT tool environment (XTM/Phrase), also Track Changes in Microsoft Word following project-specific setup instructions. Field of Expertise Clinical Research Documents (protocols and synopses, IB, ICF, Patient Sheets, Patient Diaries) Regulatory Documents (SmPC, PIL, Labels, CTD Modules) Pharmacovigilance Documents (PSUR, DSUR, RMP, SAE and AE) Must-Have Criteria Applicant must meet at least one of the following criteria: Education A degree in Translation, Linguistics, or Language Studies (or an equivalent degree) or Recognized graduate qualification in any other field, plus a minimum of two years of full-time professional experience in translation or A minimum of five years of full-time professional experience in translation Relevant translation experience At least two years of practical translation experience, specifically with life sciences (clinical trials and pharmacovigilance) and medical documents Technical Skills Familiarity with CAT tools (XTM/Phrase), License will be provided. Familiarity with Track Changes in Microsoft Word Nice-to-Have Degree in Medicine, Biology, Biochemistry, Clinical Research, Translation, Linguistics, Philology or similar In-house industry experience at a CRO or pharmaceutical company. Before Applying Please note there will be an assessment as part of our onboarding and quality procedure, please only apply if you're willing to complete our assessment.   Please ensure your latest English CV accurately reflects your Life Sciences and Medical translation experience, including years of experience specifically in Life Sciences, the document types you’ve translated, CAT tool you've used, and relevant details also your contact information (email AND phone number).   Beware of recruitment scams. Welo Global and all of its brands never recruit through direct messages on social media or WhatsApp, and never asks candidates to pay money for a job. Official emails come only from @welocalize.com, @welodata.ai, or @hire.lever.co, and all applications go through jobs.lever.co/weloglobal. Be wary of unexpected offers, generic email addresses (such as Gmail or Yahoo), and requests for fees or sensitive information. Report suspicious messages and learn more: Recognizing Scams and Confirming Legitimate Welocalize Communications – Welo Global   We look forward to receiving your application!   Job Reference: #LI-JC1

Location: Bengaluru, Karnataka, India Responsibilities: Supports UK, Ireland, Malta, Sweden, Finland, Norway, and Denmark products across the product portfolio. Supports the team with regulatory strategies (local and regional) that are in line with the business plan Supports the team with regulatory activities for National and/or European procedures (Decentralized, Mutual Recognition) as appropriate. For example, but not limited to: Prepares and compiles regulatory submissions, response to questions, renewals, post submission/approval activities (including relevant updates to external websites such as emc, medicines.ie and In-Demand) Supports ad hoc projects (e.g., compliance reviews, audit preparation etc.) Signs off on packaging material, leaflets, and SmPCs (as appropriate) Supports the compilation of the Northern Cluster team metrics for the EMEA biannual metrics report Supports all regulatory activities in Malta Ensures regulatory compliance within the department to include: The maintenance of global, regional, and local databases Adherence to processes, SOPs, work instructions, and job aids Updates to relevant local and global databases to track current product information Supports team with Calls for Information (CFI) and assist in any Pharmacovigilance- related activities within the Northern Cluster, which may include: Receiving and monitoring responses to CFIs through liaison with UK and EAME colleagues Ensuring responses are submitted in a timely manner and that they are in line with standard procedures and metrics established by the VP Regulatory Affairs in European Regulatory Provide support and responses to ad hoc requests received from UK PV group or Global Reg Med Mailbox Supports the team with regulatory activities for National and/or European procedures (Decentralized, Mutual Recognition) as appropriate. Ensures regulatory compliance within the department Experience/Qualifications: Bachelor's/Master's degree in Life Science/Pharma Minimum of 5 ~ 8 years of relevant work experience working within a Regulatory Affairs Department (e.g., pharmaceutical, cosmetic, food supplements, etc.), with direct accountability for deliverables or a combination of direct Regulatory Affairs experience of CMC, Quality, or Regulatory Operations.

Location: Remote, Worldwide Workplace: remote About Welo Life Sciences  Welo Life Sciences, a Welo Global brand, is a specialized language and technology partner serving pharmaceutical, CRO, and medical device organizations operating in regulated global markets. We deliver regulator-ready translation, linguistic validation, and localization solutions that support clinical trials, pharmacovigilance, regulatory affairs, labeling, and global commercialization. Our approach combines subject matter expertise with ISO-certified quality processes and technology-enabled workflows designed to integrate seamlessly into life sciences operations. With extensive experience supporting global product development and post-market requirements, Welo Life Sciences helps organizations accelerate timelines, protect data integrity, and maintain compliance across languages and regions. All solutions are delivered within a secure, audit-ready framework supported by seven ISO certifications.  welolifesciences.com About the Role We are looking for experienced English into Spanish (ESUS/US based) linguists specializing in Clinical-trial, Pharmacovigilance and Regulatory document translation. Key Responsibilities Translate clinical research, regulatory and pharmacovigilance documents from English to Spanish LatAm. Perform Machine Translation Post-Editing (MTPE) on machine-translated safety content. Perform Copy Edit (translation review) of translated/post-edited content for accuracy, tone, and consistency. Meet strict, non-extendable turnaround times on time-sensitive content. Work within the client's CAT tool environment (XTM/Phrase), also Track Changes in Microsoft Word following project-specific setup instructions. Field of Expertise Clinical Research Documents (protocols and synopses, IB, ICF, Patient Sheets, Patient Diaries) Regulatory Documents (SmPC, PIL, Labels, CTD Modules) Pharmacovigilance Documents (PSUR, DSUR, RMP, SAE and AE) Must-Have Criteria Applicant must meet at least one of the following criteria: Education A degree in Translation, Linguistics, or Language Studies (or an equivalent degree) or Recognized graduate qualification in any other field, plus a minimum of two years of full-time professional experience in translation or A minimum of five years of full-time professional experience in translation Relevant translation experience At least two years of practical translation experience, specifically with life sciences (clinical trials and pharmacovigilance) and medical documents Technical Skills Familiarity with CAT tools (XTM/Phrase), License will be provided. Familiarity with Track Changes in Microsoft Word Native Language Candidates must be native Spanish speakers who were born and raised in the U.S., or have been residing in the U.S. for at least 10 years and be able to demonstrate familiarity with the differences between the Spanish used in their country of origin and in the U.S. Location A candidate must be based in the U.S. Nice-to-Have Degree in Medicine, Biology, Biochemistry, Clinical Research, Translation, Linguistics, Philology or similar In-house industry experience at a CRO or pharmaceutical company. Before Applying Please note there will be an assessment as part of our onboarding and quality procedure, please only apply if you're willing to complete our assessment.   Please ensure your latest English CV accurately reflects your Life Sciences and Medical translation experience, including years of experience specifically in Life Sciences, the document types you’ve translated, CAT tool you've used, and relevant details also your contact information (email AND phone number).   Beware of recruitment scams. Welo Global and all of its brands never recruit through direct messages on social media or WhatsApp, and never asks candidates to pay money for a job. Official emails come only from @welocalize.com, @welodata.ai, or @hire.lever.co, and all applications go through jobs.lever.co/weloglobal. Be wary of unexpected offers, generic email addresses (such as Gmail or Yahoo), and requests for fees or sensitive information. Report suspicious messages and learn more: Recognizing Scams and Confirming Legitimate Welocalize Communications – Welo Global   We look forward to receiving your application!   Job Reference: #LI-JC1

Location: Remote, Worldwide Workplace: remote About Welo Life Sciences  Welo Life Sciences, a Welo Global brand, is a specialized language and technology partner serving pharmaceutical, CRO, and medical device organizations operating in regulated global markets. We deliver regulator-ready translation, linguistic validation, and localization solutions that support clinical trials, pharmacovigilance, regulatory affairs, labeling, and global commercialization. Our approach combines subject matter expertise with ISO-certified quality processes and technology-enabled workflows designed to integrate seamlessly into life sciences operations. With extensive experience supporting global product development and post-market requirements, Welo Life Sciences helps organizations accelerate timelines, protect data integrity, and maintain compliance across languages and regions. All solutions are delivered within a secure, audit-ready framework supported by seven ISO certifications.  welolifesciences.com About the Role We are looking for experienced English into Spanish (Mexico) linguists specializing in Clinical-trial, Pharmacovigilance and Regulatory document translation. Key Responsibilities Translate clinical research, regulatory and pharmacovigilance documents from English to Spanish LatAm. Perform Machine Translation Post-Editing (MTPE) on machine-translated safety content. Perform Copy Edit (translation review) of translated/post-edited content for accuracy, tone, and consistency. Meet strict, non-extendable turnaround times on time-sensitive content. Work within the client's CAT tool environment (XTM/Phrase), also Track Changes in Microsoft Word following project-specific setup instructions. Field of Expertise Clinical Research Documents (protocols and synopses, IB, ICF, Patient Sheets, Patient Diaries) Regulatory Documents (SmPC, PIL, Labels, CTD Modules) Pharmacovigilance Documents (PSUR, DSUR, RMP, SAE and AE) Must-Have Criteria Applicant must meet at least one of the following criteria: Education A degree in Translation, Linguistics, or Language Studies (or an equivalent degree) or Recognized graduate qualification in any other field, plus a minimum of two years of full-time professional experience in translation or A minimum of five years of full-time professional experience in translation Relevant translation experience At least two years of practical translation experience, specifically with life sciences (clinical trials and pharmacovigilance) and medical documents Technical Skills Familiarity with CAT tools (XTM/Phrase), License will be provided. Familiarity with Track Changes in Microsoft Word Native Language A candidate must be native in ESMX (Mexican Spanish) Nice-to-Have Degree in Medicine, Biology, Biochemistry, Clinical Research, Translation, Linguistics, Philology or similar In-house industry experience at a CRO or pharmaceutical company. Before Applying Please note there will be an assessment as part of our onboarding and quality procedure, please only apply if you're willing to complete our assessment.   Please ensure your latest English CV accurately reflects your Life Sciences and Medical translation experience, including years of experience specifically in Life Sciences, the document types you’ve translated, CAT tool you've used, and relevant details also your contact information (email AND phone number).   Beware of recruitment scams. Welo Global and all of its brands never recruit through direct messages on social media or WhatsApp, and never asks candidates to pay money for a job. Official emails come only from @welocalize.com, @welodata.ai, or @hire.lever.co, and all applications go through jobs.lever.co/weloglobal. Be wary of unexpected offers, generic email addresses (such as Gmail or Yahoo), and requests for fees or sensitive information. Report suspicious messages and learn more: Recognizing Scams and Confirming Legitimate Welocalize Communications – Welo Global   We look forward to receiving your application!   Job Reference: #LI-JC1

Location: Canada ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Senior Scientist, Risk Management & Safety Surveillance on a permanent basis. Responsibilities Position Summary The scientist will be responsible for core safety deliverables including scheduled and ad hoc aggregate reports and will serve as report owner for assigned reports (medium to large volume, standard complexity). He/She will have in- depth product knowledge and will support Safety Management Team (SMT) deliverables as required. Daily activities involve planning, conducting meetings, database searching, aggregate safety analysis and case level review, writing, and project management/coordination of strategic safety documents. He/She will partner with team members, stakeholders including Medical Safety Officers (MSOs), and a vendor. Primary Responsibilities: •     Ensure timely, quality reports/safety analyses related to core deliverables with oversight as appropriate •     Collaborate with Therapeutic Area Safety Head (TASH), MSO, Safety Surveillance Physician (SSP) and other stakeholders on strategy development •     Initiate, conduct, and oversee searches of internal and external databases •     Perform and/or lead aggregate safety analysis and case level review •     Author, contribute, and coordinate the preparation of core safety deliverables •     Ensure commitments (e.g., Pharmacovigilance Agreements (PVAs) and assessment reports) are met •     Partner with vendor to develop reports/deliverables •     Provide SMT support as needed •     Act as ad hoc member for assigned products as appropriate •     Recognize potential issues and or safety issues and escalate to the attention of    the report owner, line manager, or MSO •     Ability to understand nature of adverse drug reactions and complex associations •     Maintains a high level of flexibility and ability to reprioritize ones work and others •     Attention to detail and ability to analyze data in broader context •     Ability to work across multiple functions and therapeutic areas •     Review regulatory assessor comments/requests and accommodate/address as appropriate with guidance Training/Meetings/Department Initiatives: •     Participate in cross-functional training of relevant stakeholders •     Attend departmental meetings and trainings •     Participate in department and/or cross-functional initiatives Secondary Responsibilities: •     Safety Management Teams (SMT) for assigned products - Lead SMT meeting.  Lead and drive discussions and formulate decisions along with core members •     Risk management plans - Provide guidance on RMP creation and updates.  Reviews and align approvals with oversight leads of the Risk Management plan •     Periodic Benefit Risk Evaluation Report (PBRER)/ Periodic Safety Update Report (PSUR) - Reviews and align approvals with lead oversight.  Leads strategy of the PBRER process. •     Health authority queries -Work with MSO, scientist to organize data, review cases, literature, write Marketing Authorization Holder (MAH) comments •     Participating Affiliate Core Data Sheets (CCDS), US and EU prescribing information updates - Form part of the label working group and provide guidance related to the label updates. •     Signal Validation and Evaluations - Work with Scientist to review preliminary data to determine if the signal is valid and would require further evaluation. Lead and drive the signal evaluation process •     IB updates for safety sections - Evaluate clinical data for ADRs, assist with section 5 and Reference Standard Information (RSI) tables as needed •     DSURs - Reviews and aligns Safety approvals with lead oversight. •     Addendum to Clinical Overviews - Provide support with review, and characterization of risks, data review •     Literature reviews for class effects and ad hoc reports -Review articles and create MAH Comments for assessment of the articles •     Product Safety Strategy (PSS) - Review the risks documented in the PSS and oversee the updates as necessary. Align approval of the PSS updates with oversight. •     Handing Level 2 Escalations/HHE - Participate in level 2 escalations and assess whether there is a Safety impact and an HHE is needed. Lead and drive the HHE process. •     Clinical Development Team (CDT), Local Working Group (LWG) and other cross functional meeting participation - Participate and provide safety inputs as required Minimum Qualifications Education/Experience: ·       Bachelor’s degree in Health or Biomedical Science and six to eight years of industry experience or equivalent, or Advanced degree (preferred) in Health or Biomedical Science and four to six years of industry experience or equivalent) ·       Physician (MD or equivalent) generally requires 2-5 years of pharmacovigilance experience or other relevant experience (e.g., Clinical research, Medical Affairs). Demonstrated skills in clinical medicine with at least 3 years of clinical practice experience is preferred. ·       Clinical/medical writing or pharmacovigilance experience preferred ·       Strong English verbal and written communication skills. ·       Demonstrated knowledge of principles of drug development, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development as well as global safety regulations, is highly preferred. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-PB1 #LI-Remote AI: Our hiring process includes AI screening for keywords and minimum qualifications. Recruiters review all results. Vacancy: This posting is for an existing vacancy. Open Date: 22-09-2026 Close Date: 06-11-2026 The following disclaimer for CA must be included (remove the equal opportunities wording from the advert template in the bottom paragraph and replace with the following & delete these instructions): ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity.  We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-5709 x 301. We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA") , personal information is collected under the authority of the Act and will only be used for candidate selection. The base salary pay range represents the anticipated low and high range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Canada Pay Range $80 — $115 CAD

Location: Pasig, Philippines Job Description: The Scientist/Senior Scientist – QPPV Office, Local Safety Support & Regulatory Intelligence is a safety expert who provides safety oversight, in their allocated region, for the Consumer portfolio of products throughout the life cycle of the products, including new product development. The incumbent works closely with and partners with the RMSO to proactively collaborate with regional colleagues in R&D, Regulatory, and Quality. The incumbent works closely alongside LPV country team leads in their region. The incumbent is a key contributor to regional safety deliverables and evaluations. The incumbent will provide backup to the RMSO and can represent the RMSO at meetings and for safety deliverables. Key Responsibilities: Safety evaluations and clinical insights contributing to the completion of the regional safety deliverables for the company portfolio. Identification, communication and management of potential and known safety risks. Cross-functional collaboration within and outside KMS. Ability to influence and work effectively with business partners and colleagues. A vocal and visible champion of safety insights as a key input into product development and post-market safety surveillance strategy. Work with RMSO (Regional Medical Safety Officer) to partner and align with regional cross-functional business partners and generate relevant safety assessments and reviews for their allocated region, for the Consumer portfolio of products, throughout the life cycle of the products, including new product development. Work closely with the RMSO and works collaboratively with others within KMS. Collaborates with the company's functional areas and LPV in their region. Job Competencies: Carry out structured problem-solving and Credo-based decision-making skills. Understand the clinical application of the technology/medication and assess the potential for a hazard to result in a harm. Critically evaluate safety data from multiple sources (post-market reports, literature, etc.), and communicate to align with GRASP (Global Risk Assessment Safety Physician) safety decisions. Work with diverse topics simultaneously. Provide assertive inputs on issues relating to patient/ consumer safety. Communicate effectively with cross-functional stakeholders. Job Complexities: Handle large data sets and draw objective conclusions using appropriate analyses. Collaborate with multiple functions and lines of business. Handle many products/product families simultaneously. Manage complex products. Meet timelines for deliverables according to SOPs. Experience and Qualifications: Licensed MD with at least 3 years of clinical experience Two or more years of industry experience in foundational to intermediate Pharmacovigilance . Ability to analyze, interpret and present complex data in a concise and understandable scientific manner, both orally and in written format, is essential. Brings strong project management and organizational skills, with the ability to coordinate multiple safety-related activities, manage timelines and deliverables, represent the company in cross-functional meetings, and collaborate effectively with international teams across EMEA. Demonstrates the ability to critically assess PV data, identify clinically relevant patterns or trends, and translate safety findings into meaningful clinical insights. Possesses a good understanding of adverse events, serious adverse events, case assessment, safety signals, and benefit-risk considerations. Attention to detail; Diligence in record-keeping and records organization; Ability to manage high workload and critical issues; Computer-literate and proficient in MS Office applications. Team player; Displays initiative; Strong communication and presentation skills. Strong collaborative and interpersonal skills; Results-oriented and able to independently create and deliver; Ability to thrive in a global, cross-functional environment.

Location: Yerevan, Armenia ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Senior Associate, Aggregate Reporting Physician on a permanent basis. Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career! Position Overview: The Senior Associate, Aggregate Reporting Physician position is responsible for developing, reviewing, and maintaining high-quality safety and pharmacovigilance documents that support the safety surveillance and regulatory compliance of consumer health products. It requires the ability to synthesize data from multiple sources, including individual case safety reports (ICSRs), aggregate safety data, clinical studies, epidemiological research, literature reviews, post-marketing surveillance, signal detection activities, and other safety data sources. The successful candidate will transform complex safety information into clear, concise, and scientifically accurate documents that support global pharmacovigilance activities and regulatory submissions and will work closely with Drug Safety, Medical Affairs, Regulatory Affairs, Clinical Development, Quality, and R&D teams to ensure consistent, evidence-based communication of product safety information. Main Job Tasks and Responsibilities: Prepare, review, and maintain pharmacovigilance and risk management documents for consumer health products. Synthesize safety information from multiple sources, including: Individual Case Safety Reports (ICSRs), Aggregate safety data analyses, Clinical trial safety data, Post-marketing surveillance data, Epidemiology studies, Published literature, Signal detection and evaluation activities, Benefit-risk assessments, Health Authority Assessment Reports. Draft and support the preparation of: Periodic Safety Update Reports (PSURs/PBRERs/PADERs), Ad Hoc Safety Reports, Development Safety Update Reports (DSURs), Signal assessment reports, Aggregate safety reports, Risk management documentation, Health authority responses, Safety narratives, Safety sections of regulatory submissions, Safety surveillance reports and presentations, Analysis and evaluation for the Safety Management Teams (SMT). Collaborate with Safety Scientists, Medical Reviewers and others to evaluate emerging safety information and communicate findings effectively. Assist in the interpretation of safety trends, potential signals, and benefit-risk considerations. Support literature surveillance activities and summarize relevant safety findings. Contribute to the development of safety conclusions and evidence-based recommendations. Support the preparation, review, and analysis of risk management activities and reports. Ensure all documents comply with global pharmacovigilance regulations, company SOPs, and applicable guidance documents. Maintain high standards of scientific accuracy, consistency, grammar, and document quality. Perform quality control reviews of safety documents and ensure timely delivery of assigned projects. Support inspection and audit readiness activities through accurate documentation practices. Education and Experience: Advanced degree required: PharmD, PhD, MD, MPH, MS, or equivalent scientific discipline. 3–6 years of experience in pharmacovigilance, drug safety, medical writing, regulatory writing, or related pharmaceutical, consumer health, or medical device industries. Experience preparing safety and pharmacovigilance documents preferred. Familiarity with global pharmacovigilance regulations and safety reporting requirements. Experience working in a matrixed environment with multiple stakeholders. Strong understanding of: Clinical research methodologies, Epidemiology and biostatistics, Evidence-based medicine, Regulatory and scientific communication requirements, Safety and benefit-risk assessment principles Expertise in literature evaluation and scientific data interpretation. Ability to critically analyze multiple complex scientific information and identify key insights to drive product safety. Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) with strong document formatting, data analysis, and presentation capabilities. Excellent medical writing, editing, and proofreading skills. Exceptional grammar, attention to detail, and document quality standards. Strong analytical and critical thinking capabilities. Effective project management and organizational skills Exceptional Communication and Presentation Skills, with the ability to convey complex clinical and scientific information clearly and effectively to diverse audiences. Ability to work independently while managing multiple priorities and deadlines. Our Benefits: Flexible Working Hours Full performance and development process with end of year reviews Team events and end of year party Employee satisfaction survey - your feedback is important for continuous improvement Health Insurance The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare! Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.  The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Location: Iceland Freelance opportunity in Iceland! Join our global team as a Local Pharmacovigilance Support Person and Medical Information Specialist in Iceland. Local Pharmacovigilance Support Person and Medical Information Specialist is responsible for managing daily operations, ensuring compliance, exchanging safety information and serving as a contact for timely safety processing. Position is remote for 0.1 FTE position in Iceland, working in close collaboration with Nordic local safety officers and medical information specialists. You have energy and motivation to work in a team and to gain more experience? Submit your CV in the English language for consideration. Responsibilities: Perform local PV operations and ensure compliance with safety regulations and procedures Manage ICSRs and FUs Review local literature Review local legislation Perform PV trainings to MAH employees Handle Medical Information Requests Support Biomapas Clients with other PV related tasks Requirements Degree in Medicine, Biomedicine, Pharmacy, or Nurse Fluent in written and spoken English and native Icelandic Preferably at least 2 years experience in pharmacovigilance In-depth, demonstrated experience in most areas pertaining to pharmacovigilance and pharmacovigilance legislation Excellent knowledge of local and international regulations (ICH, EU GVP Modules) Analytical skills to understand, analyze, interpret, and present scientific data Ability to interpret and apply global and local drug safety regulations High motivation to develop and learn within the team

Location: Kyiv, Ukraine Join our global team as a Regulatory Affairs Specialist in Ukraine. Regulatory Affairs Specialist is responsible for assigned projects and related tasks, applications and dossiers submissions, communication with clients and national authorities. Position is in Ukraine, Kyiv. All CV's must be submitted in English language for an assessment. Responsibilities: Prepare and maintain regulatory submissions, registrations, renewals, variations for medicinal products and medical devices, and notifications for food supplements Ensure compliance of products, labeling, packaging, and promotional materials with Ukrainian regulations Monitor regulatory changes and assess their impact on the product portfolio Liaise with regulatory authorities and external partners Support product launches, lifecycle management activities, and compliance initiatives Support pharmacovigilance activities, including the submission of safety-related documentation to regulatory authorities. Coordinate implementation of safety-related labeling updates and variations Collaborate with local and global PV teams on safety communications, regulatory commitments, and inspection readiness Maintain regulatory documentation and databases Vendors management Participate in audits Requirements University degree in Pharmacy, Life Science, Medicine, or a related field Fluent English, and Ukrainian languages 4-5 years experience in Regulatory Affairs with medicinal products, medical devices and food supplements Excellent knowledge in the field of registration of medicinal products, medical devices and food supplements according to national rules Time management skills Ability to solve problems and make decisions Benefits Professional growth and career opportunities International team and environment Bonus based on annual performance Personal accident and business trip insurance Additional health insurance Remote/home based Rewarding referral policy Team building, global meetings