Фармацевтика и клинические исследования вакансии

Location: United States Gramian Consultancy is a boutique consultancy specializing in IT professional services and engineering talent solutions. With a strong background in software engineering and leadership, we help companies build high-performing teams by matching them with professionals who truly fit their needs. Role Overview We are looking for an experienced Clinical Pharmacist to contribute to an AI training and evaluation project focused on medication safety, pharmacotherapy, longitudinal chart review, and clinical decision-making. The role involves creating and reviewing complex medication-related clinical tasks, long-chart scenarios, gold-standard answers, and evaluation rubrics . You will assess whether outputs reflect appropriate medication selection, dosing, monitoring, interactions, contraindications, reconciliation, and patient-safety considerations. CONTRACT: Contractor assignment, 12 weeks COMMITMENT: Part-time or Full-time (20-40h/week) LOCATIONS: Remote - USA PROCESS: The selection will be made based on an online questionnaire and resume/education/certification Key Responsibilities Develop high-quality clinical pharmacy cases and benchmark tasks . Review longitudinal charts, medication histories, laboratory results, diagnoses, and treatment plans. Identify medication-related risks, inconsistencies, omissions, and unsafe recommendations. Evaluate AI-generated outputs for pharmacotherapy accuracy, appropriateness, safety, and clinical reasoning . Create gold-standard answers and clinically defensible reference solutions. Review medication selection, dosing, monitoring, contraindications, interactions, and therapeutic alternatives. Assess medication reconciliation, transitions of care, and discharge medication plans . Apply structured rubrics to evaluate reasoning, terminology, documentation quality, and patient-safety implications. Review tasks involving polypharmacy, renal or hepatic dosing, antimicrobial therapy, high-risk medications, or chronic disease management. Participate in calibration, peer review, and iterative refinement of clinical content. Requirements PharmD or equivalent pharmacy degree . Active pharmacist license in the United States. Approximately 3+ years of professional clinical pharmacy experience . Current or recent clinical practice within the last 3 years. Strong experience with medication management, pharmacotherapy, and medication safety. Ability to interpret complex medical records, laboratory data, diagnoses, and treatment plans. Strong clinical reasoning and ability to identify unsafe or incomplete medication recommendations. Strong written English and ability to provide clear, clinically defensible reasoning.

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

Обязанности: — Обеспечение эффективного фармаконадзора на территории Беларуси. — Сбор, обработка и хранение информации о безопасности лекарственных препаратов. — Взаимодействие с уполномоченным органом Республики Беларусь. Требования: — Готовность посещать уполномоченный орган несколько раз в месяц. — Медицинское образование (предпочтительно). — Фармацевтическое, химическое или биологическое образование (возможно). — Ответственность. — Внимательность. — Организованность.

Обязанности: — Обеспечение эффективного фармаконадзора на территории Беларуси. — Сбор, обработка и хранение информации о безопасности лекарственных препаратов. — Взаимодействие с уполномоченным органом Республики Беларусь. Требования: — Готовность посещать уполномоченный орган несколько раз в месяц. — Медицинское образование (предпочтительно). — Фармацевтическое, химическое или биологическое образование (возможно). — Ответственность. — Внимательность. — Организованность.

Location: United States Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Regulatory Affairs CMC Consultant for 12 months Contract with possibility of extension to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. About the Role We are seeking an experienced Regulatory CMC professional to support Client’s pharmaceutical and self-care portfolio. This role will provide regulatory CMC expertise across new product development, lifecycle management, post-approval changes, and global regulatory submissions . The successful candidate will partner closely with Regulatory Affairs, R&D, Supply Chain, Quality, and other cross-functional teams to develop and implement effective CMC regulatory strategies. Key Responsibilities Lead or support Regulatory CMC strategy for new product development and lifecycle management programs. Provide CMC regulatory guidance for pharmaceutical and self-care products across global markets. Develop, review, and maintain CTD Module 2.3 and Module 3 documentation. Prepare and review CMC content for regulatory submissions, including new applications, variations, and post-approval changes. Assess proposed CMC changes for regulatory impact, compliance, risks, and submission requirements. Provide regulatory guidance on manufacturing, formulation, analytical methods, specifications, stability, packaging, and related CMC topics. Act as the CMC representative on cross-functional product development and lifecycle management teams. Partner with R&D, Manufacturing, Quality, Supply Chain, and Regulatory colleagues to resolve CMC issues and develop practical regulatory strategies. Support regulatory agency interactions and responses to CMC-related questions, as required. Manage regulatory risks and develop appropriate mitigation and contingency strategies. Ensure ongoing regulatory compliance and successful implementation of approved CMC changes. Contribute to process improvements, simplification initiatives, and development of effective CMC ways of working. Required Qualifications Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences , or a related discipline. Strong experience in Regulatory Affairs CMC and/or pharmaceutical product development . Experience with CTD Modules 2.3 and 3 and CMC submission documentation. Knowledge of global regulatory requirements related to pharmaceutical CMC. Experience with new product development and post-approval lifecycle management . Strong understanding of CMC regulatory requirements involving manufacturing, formulation, analytical testing, specifications, and stability. Experience working effectively with cross-functional teams. Strong project management, communication, problem-solving, and stakeholder-management skills. Preferred Experience Experience supporting OTC, self-care, consumer health, or pharmaceutical products . Experience working across multiple global markets and regulatory regions. Experience interacting with health authorities or supporting responses to regulatory questions. Ability to influence cross-functional teams and provide clear, practical regulatory guidance. What You’ll Bring We are looking for someone who combines strong technical CMC expertise with excellent regulatory judgment, communication, and collaboration skills. The ideal candidate will be comfortable working in a global, cross-functional environment and managing multiple CMC programs and priorities. 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 #Contract

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: Montreal, Canada Rejoignez un poste où la science rencontre la stratégie et où votre expertise façonne l’avenir du développement de médicaments. En tant que Directeur pharmacométricien , vous dirigerez des projets de modélisation et de simulation à fort impact au sein d’un environnement dynamique de pharmacologie clinique, de modélisation et de simulation (CPMS). Vous dirigerez des équipes, encadrerez des pharmacométriciens et fournirez des conseils stratégiques aux clients lors des étapes clés du développement. Ce poste vous offre également l’opportunité de représenter les clients dans leurs interactions avec les organismes de réglementation. Si vous aimez travailler en collaboration et relever des défis scientifiques complexes, voici votre chance d’avoir un impact significatif. Step into a role where science meets strategy and your expertise shapes the future of drug development. As a Director Pharmacometrician , you’ll lead high-impact modeling and simulation efforts within a dynamic Clinical Pharmacology, Modeling and Simulation (CPMS) environment. You’ll guide teams, mentor pharmacometricians, and provide strategic insight to clients at key development milestones. This role also offers the opportunity to represent clients in interactions with regulatory agencies. If you thrive on collaboration and solving complex scientific challenges, this is your chance to make a meaningful impact. À propos du poste Ce poste allie leadership scientifique et impact stratégique : vous dirigerez des analyses pharmacocinétiques de population tout en développant des approches innovantes pour à améliorer l’efficacité et la précision. Vous serez chargé de concevoir, d’analyser et d’interpréter des études de pharmacologie clinique, de fournir des conseils stratégiques aux clients et de contribuer à la rédaction de documents réglementaires ainsi qu’aux interactions avec les organismes de réglementation. De plus, vous entretiendrez les relations avec les clients, soutiendrez le développement des affaires et resterez à la pointe des avancées en pharmacocinétique et pharmacodynamique afin de favoriser l’amélioration continue. Vos principales responsabilités comprendront, sans s'y limiter : Diriger et réaliser des analyses pharmacocinétiques de population à l'aide d'outils et de méthodologies de modélisation avancés Élaborer et mettre en œuvre des approches innovantes pour améliorer l'efficacité et la précision des analyses pharmacocinétiques Concevoir, analyser et interpréter des études de pharmacologie clinique (rénale, hépatique, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) et fournir des conseils pour optimiser les stratégies d'échantillonnage pharmacocinétique et de posologie Fournir des conseils stratégiques aux clients, en assumant la responsabilité des livrables et en élaborant des plans de pharmacologie clinique Rédiger et réviser les rapports pharmacocinétiques ainsi que les sections de pharmacologie clinique des documents réglementaires Représenter les clients dans les interactions avec les autorités réglementaires et contribuer au développement des affaires et à la gestion des relations About the role This role combines scientific leadership and strategic impact, leading population PK analyses while developing innovative approaches to improve efficiency and accuracy. You will design, analyze, and interpret clinical pharmacology studies, provide strategic guidance to clients, and contribute to regulatory documents and agency interactions. In addition, you’ll foster client relationships, support business development, and stay at the forefront of PK/PD advancements to drive continuous improvement. Your main responsibilities will include but not limited to: Lead and conduct population PK analyses using advanced modeling tools and methodologies Develop and implement innovative approaches to enhance the efficiency and accuracy of PK analysis Design, analyze, and interpret clinical pharmacology studies (renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and provide guidance to optimize pharmacokinetic sampling and dosing strategies Provide strategic guidance to clients, owning deliverables and developing clinical pharmacology plans Author and review PK reports and clinical pharmacology sections of regulatory documents Represent clients in regulatory interactions and contribute to business development and relationship management Requirements À propos de vous Si vous êtes un professionnel de la pharmacologie clinique motivé, fort de 10 ans d’expérience dans le développement de médicaments et la pharmacométrie, et que vous possédez un esprit analytique aigu ainsi qu’une expertise dans l’utilisation d’outils tels que NONMEM, Pirana et R pour fournir des analyses percutantes, tout en étant orienté vers le client et en étant un leader naturel qui s’épanouit dans des environnements dynamiques, alliant réflexion stratégique, excellentes compétences en communication et sens des affaires pour établir des relations et obtenir des résultats, ce poste est fait pour vous. Pour réussir, nous recherchons les qualités et comportements suivants : Diplôme en sciences de la vie, en soins de santé et/ou en administration des affaires Au moins 10 ans d’expérience professionnelle pertinente, notamment dans le développement de médicaments, la pharmacologie clinique et la pharmacométrie Une expérience en matière de réglementation, y compris la rédaction de rapports réglementaires, est indispensable. Expérience des soumissions réglementaires, y compris les demandes d'autorisation de mise en examen (IND), les demandes d'autorisation de clinique (CTA), les réunions réglementaires et les soumissions de demandes d'autorisation de mise en marché (NDA/BLA/MAA) Maîtrise des logiciels NONMEM, Pirana et R souhaitée Excellentes compétences en organisation, en négociation et en gestion financière About You If you are a driven clinical pharmacology professional with 10 years of experience in drug development and pharmacometrics and you bring sharp analytical thinking and expertise in tools like NONMEM, Pirana, and R to deliver high-impact insights while being client-focused and a natural leader who thrives in fast-paced environments, combining strategic thinking, strong communication, and business acumen to build relationships and drive results, this role is for you. To be successful we are looking for the following traits and behaviors: Life science, healthcare and/or business degree Minimum 10 years of relevant work experience, including experience in drug development, clinical pharmacology, and pharmacometrics Regulatory experience including regulatory report writing essential. Experience with regulatory submissions including INDs, CTAs, regulatory meetings and NDA/BLA/MAA submissions Proficiency in NONMEM, Pirana, and R software preferred Excellent organizational, negotiating and financial skills Benefits À propos d'Allucent Notre mission est de contribuer à la mise au point de nouveaux traitements. Travailler chez Allucent, c'est retrousser ses manches et mettre à profit ses compétences, son expertise et ses connaissances uniques pour établir des partenariats avec nos clients dans leur quête de nouveaux traitements destinés à améliorer la vie des patients. Si vous êtes passionné(e) par l'aide apportée aux clients pour le développement de nouveaux produits pharmaceutiques et biologiques, si vous avez l'esprit d'entreprise et si vous êtes prêt(e) à rejoindre d'autres leaders dans les domaines de la science, des affaires et des opérations, nous serions ravis d'en savoir plus sur la manière dont nous pouvons nous aider mutuellement à grandir. Ensemble, nous BRILLONS. Découvrez-en plus sur nos valeurs. Les avantages de travailler chez Allucent comprennent : Ensemble complet d'avantages sociaux par site Des salaires compétitifs par site Un budget départemental dédié à la formation et à l'étude pour favoriser le développement professionnel Des horaires de travail flexibles (dans la mesure du raisonnable) La possibilité de travailler télétravail/en mode hybride* selon le site Possibilités de leadership et de mentorat Participation à notre programme de parrainage en tant que nouvel employé ou employé existant Des opportunités d'évolution interne et de progression de carrière Programme de recommandation interne des employés financièrement avantageux About Allucent Our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and 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. Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on location Leadership and mentoring opportunities Participation in our Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Avertissements : *Notre politique de travail au bureau encourage un environnement de travail dynamique, en prescrivant un minimum de 2 jours par semaine au bureau pour les employés se trouvant à une distance raisonnable de l'un de nos bureaux internationaux . L'équipe Allucent Talent Acquisition gère le processus de recrutement et d'embauche pour Allucent (US) LLC et ses filiales (collectivement « Allucent »). Allucent n'accepte pas les CV non sollicités provenant de recruteurs tiers ni les demandes de collaboration non sollicitées pour l'un de nos postes vacants. Les CV non sollicités envoyés aux employés d'Allucent n'obligent pas Allucent à embaucher ces personnes à l'avenir ni à verser une rémunération potentielle à une agence de recrutement tierce. Les candidatures ne doivent jamais être soumises directement à nos responsables du recrutement, à nos employés ou à nos services des ressources humaines. Disclaimers: *Our office-based work policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within reasonable distance from one of our global offices . “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.” #LI-Remote #LI-Hybrid #LI-DE

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.”