Location: Pasig City, Philippines
Primary Responsibilities:
Awareness and understanding of relevant GVP modules.
Perform medical review of non-serious & serious ICSRs with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance.
Experience of medical review of ICSRs received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials.
Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases etc.
Support triage of cases and determine seriousness and relatedness across products as assigned.
Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling and review narrative.
Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas.
Involve in process improvement activities such as implementation of quality control process.
Provide medical guidance and expert opinion on the cases to the data entry associates and quality reviewers to help resolve queries.
Identify and resolve case issues, coordinate with client therapeutic teams and within functional team and manage as appropriate.
Maintain PV expertise and understanding of international safety regulations and guidelines.
Responsible for completing the MR activities in the safety database within the stipulated time to comply with service level agreements and regulatory timelines.
Provide timely feedback to case processors on the errors/ discrepancies noted.
Assist in training/mentoring of other case processing/medical review personnel as necessitated.
Adapt to different client case processing conventions and multi-task as per business needs.
Perform ad-hoc tasks as advised by the team lead/manager with quality and compliance as per project requirement.
Participate in organizational activities to meet objectives suitable for the role/area of expertise.
Candidate Profile:
Medical Physician with at least 2 years of experience as Medical Reviewer for ICSRs.
Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements.
Training and mentoring skills (GVP concepts & medical aspects such as disease condition, product portfolio etc).
Must have hands-on experience with MS Office applications (Outlook, Excel, Word, Power Point etc).
Location: San Francisco, CA
About Anthropic
Anthropic’s mission is to create reliable, interpretable, and steerable AI systems. We want AI to be safe and beneficial for our users and for society as a whole. Our team is a quickly growing group of committed researchers, engineers, policy experts, and business leaders working together to build beneficial AI systems.
About the role:
When you see what modern language models are capable of, do you wonder, "How do these things work? How can we trust them?"
The Interpretability team at Anthropic is working to reverse-engineer how trained models work because we believe that a mechanistic understanding is the most robust way to make advanced systems safe. We’re looking for researchers and engineers to join our efforts.
People mean many different things by "interpretability". We're focused on mechanistic interpretability, which aims to discover how neural network parameters map to meaningful algorithms. Some useful analogies might be to think of us as trying to do "biology" or "neuroscience" of neural networks using “microscopes” we build, or as treating neural networks as binary computer programs we're trying to "reverse engineer".
A few places to learn more about our work and team at a high level are
this introduction to Interpretability
from our research lead,
Chris Olah
; a
discussion of our work
on the
Hard Fork podcast
produced by the New York Times, and this
blog post
(and accompanying video) sharing more about some of the engineering challenges we’d had to solve to get these results. Some of our team's notable publications include
A Mathematical Framework for Transformer Circuits
,
In-context Learning and Induction Heads
,
Toy Models of Superposition
,
Scaling Monosemanticity
, and our Circuits’
Methods
and
Biology
papers. This work builds on ideas from members' work prior to Anthropic such as the
original circuits thread
,
Multimodal Neurons
,
Activation Atlases
, and
Building Blocks
.
We aim to create a solid foundation for mechanistically understanding neural networks and making them safe (see our
vision post
). In the short term, we have focused on resolving the issue of "superposition" (see
Toy Models of Superposition
,
Superposition, Memorization, and Double Descent
, and our
May 2023 update
), which causes the computational units of the models, like neurons and attention heads, to be individually uninterpretable, and on finding ways to decompose models into more interpretable components. Our subsequent
work
found millions of features in Sonnet, one of our production language models, represents progress in this direction. In our most recent work, we develop methods that allow us to build circuits using features and use this circuits to understand the mechanisms associated with a model's computation and study specific examples of multi-hop reasoning, planning, and chain-of-thought faithfulness on Haiku 3.5, one of our production models.” This is a stepping stone towards our overall goal of mechanistically understanding neural networks.
We often collaborate with teams across Anthropic, such as Alignment Science and Societal Impacts to use our work to make Anthropic’s models safer. We also have an
Interpretability Architectures project
that involves collaborating with Pretraining.
Responsibilities:
Develop methods for understanding LLMs by reverse engineering algorithms learned in their weights
Design and run robust experiments, both quickly in toy scenarios and at scale in large models
Create and analyze new interpretability features and circuits to better understand how models work.
Build infrastructure for running experiments and visualizing results
Work with colleagues to communicate results internally and publicly
You may be a good fit if you:
Have a strong track record of scientific research (in any field), and have done
some
work on Interpretability
Enjoy team science – working collaboratively to make big discoveries
Are comfortable with messy experimental science. We're inventing the field as we work, and the first textbook is years away
You view research and engineering as two sides of the same coin. Every team member writes code, designs and runs experiments, and interprets results
You can clearly articulate and discuss the motivations behind your work, and teach us about what you've learned. You like writing up and communicating your results, even when they're null
To learn more about the skills we look for and how to prepare for this role, see our blog post –
So You Want to Work in Mechanistic Interpretability?
Familiarity with Python is required for this role.
Role Specific Location Policy:
This role is based in San Francisco office; however, we are open to considering exceptional candidates for remote work on a case-by-case basis.
The annual compensation range for this role is listed below.
For sales roles, the range provided is the role’s On Target Earnings ("OTE") range, meaning that the range includes both the sales commissions/sales bonuses target and annual base salary for the role.
Annual Salary:
$350,000
—
$850,000 USD
Logistics
Minimum education:
Bachelor’s degree or an equivalent combination of education, training, and/or experience
Required field of study:
A field relevant to the role as demonstrated through coursework, training, or professional experience
Minimum years of experience:
Years of experience required will correlate with the internal job level requirements for the position
Location-based hybrid policy:
Currently, we expect all staff to be in one of our offices at least 25% of the time. However, some roles may require more time in our offices.
Visa sponsorship:
We do sponsor visas! However, we aren't able to successfully sponsor visas for every role and every candidate. But if we make you an offer, we will make every reasonable effort to get you a visa, and we retain an immigration lawyer to help with this.
For roles performing work in California:
We will consider for employment all qualified applicants, including those with arrest or conviction records or criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the San Francisco Fair Chance Ordinance, the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance, the Los Angeles County Fair Chance Ordinance for Employers, and the California Fair Chance Act.
We encourage you to apply even if you do not believe you meet every single qualification.
Not all strong candidates will meet every single qualification as listed. Research shows that people who identify as being from underrepresented groups are more prone to experiencing imposter syndrome and doubting the strength of their candidacy, so we urge you not to exclude yourself prematurely and to submit an application if you're interested in this work. We think AI systems like the ones we're building have enormous social and ethical implications. We think this makes representation even more important, and we strive to include a range of diverse perspectives on our team.
Your safety matters to us.
To protect yourself from potential scams, remember that Anthropic recruiters only contact you from @anthropic.com email addresses. In some cases, we may partner with vetted recruiting agencies who will identify themselves as working on behalf of Anthropic. Be cautious of emails from other domains. Legitimate Anthropic recruiters will never ask for money, fees, or banking information before your first day. If you're ever unsure about a communication, don't click any links—visit
anthropic.com/careers
directly for confirmed position openings.
How we're different
We believe that the highest-impact AI research will be big science. At Anthropic we work as a single cohesive team on just a few large-scale research efforts. And we value impact — advancing our long-term goals of steerable, trustworthy AI — rather than work on smaller and more specific puzzles. We view AI research as an empirical science, which has as much in common with physics and biology as with traditional efforts in computer science. We're an extremely collaborative group, and we host frequent research discussions to ensure that we are pursuing the highest-impact work at any given time. As such, we greatly value communication skills.
The easiest way to understand our research directions is to read our recent research. This research continues many of the directions our team worked on prior to Anthropic, including: GPT-3, Circuit-Based Interpretability, Multimodal Neurons, Scaling Laws, AI & Compute, Concrete Problems in AI Safety, and Learning from Human Preferences.
Come work with us!
Anthropic is a public benefit corporation headquartered in San Francisco. We offer competitive compensation and benefits, optional equity donation matching, generous vacation and parental leave, flexible working hours, and a lovely office space in which to collaborate with colleagues.
Guidance on Candidates' AI Usage:
Learn about
our policy
for using AI in our application process.
Location: San Francisco, CA
About Anthropic
Anthropic’s mission is to create reliable, interpretable, and steerable AI systems. We want AI to be safe and beneficial for our users and for society as a whole. Our team is a quickly growing group of committed researchers, engineers, policy experts, and business leaders working together to build beneficial AI systems.
Note: we don't have open Research Manager positions on the Interpretability team at this time. However, we're actively growing our team of
Research Engineers
and
Research Scientists
. If you're excited about interpretability research and open to an individual contributor role, we encourage you to apply.
About the Interpretability team
When you see what modern language models are capable of, do you wonder, "How do these things work? How can we trust them?"
The Interpretability team’s mission is to reverse engineer how trained models work, and Interpretability research is one of Anthropic’s core research bets on AI safety. We believe that a mechanistic understanding is the most robust way to make advanced systems safe.
People mean many different things by "interpretability". We're focused on mechanistic interpretability, which aims to discover how neural network parameters map to meaningful algorithms. Some useful analogies might be to think of us as trying to do "biology" or "neuroscience" of neural networks, or as treating neural networks as binary computer programs we're trying to "reverse engineer".
We aim to create a solid scientific foundation for mechanistically understanding neural networks and making them safe (see our
vision post
). We have focused on resolving the issue of "superposition" (see
Toy Models of Superposition
,
Superposition, Memorization, and Double Descent
, and our
May 2023 update
), which causes the computational units of the models, like neurons and attention heads, to be individually uninterpretable, and on finding ways to decompose models into more interpretable components. Our subsequent
work
which found millions of features in Claude 3.0 Sonnet, one of our production language models, represents progress in this direction. In our
most recent work
, we developed methods that allow us to build circuits using features and use these circuits to understand the mechanisms associated with a model's computation and study specific examples of multi-hop reasoning, planning, and chain-of-thought faithfulness on Claude Haiku 3.5, one of our production models.” This is a stepping stone towards our overall goal of mechanistically understanding neural networks.
A few places to learn more about our work and team are this
introduction to Interpretability
from our research lead,
Chris Olah, Stanford CS25 lecture given by Josh Batson, and
TWIML AI podcast
with Emmanuel Ameisen.
Some of our team's notable publications include and our Circuits’
Methods
and
Biology
papers,
Scaling Monosemanticity: Extracting Interpretable Features from Claude 3 Sonnet
,
Towards Monosemanticity: Decomposing Language Models With Dictionary Learning
,
A Mathematical Framework for Transformer Circuits
,
In-context Learning and Induction Heads
, and
Toy Models of Superposition
. This work builds on ideas from members' work prior to Anthropic such as the
original circuits thread
,
Multimodal Neurons
,
Activation Atlases
, and
Building Blocks
.
About the role
As a manager on the Interpretability team, you'll support a team of expert researchers and engineers who are trying to understand at a deep, mechanistic level, how modern large language models work internally.
Few things can accelerate this work more than great managers. Your work as manager will be critical in making sure that our fast-growing team is able to meet its ambitious safety research goals over the coming years. In this role, you will partner closely with an individual contributor research lead to drive the team's success, translating cutting-edge research ideas into tangible goals and overseeing their execution. You will manage team execution, careers and performance, facilitate relationships within and across teams, and drive the hiring pipeline.
If you're more interested in making individual direct technical contributions to our research as the primary focus of your role, feel free to apply to our
Research Scientist
or
Research Engineer
roles instead.
Key responsibilities
Partner with a research lead on direction, project planning and execution, hiring, and people development
Set and maintain a high bar for execution speed and quality, including identifying improvements to processes that help the team operate effectively
Coach and support team members to have more impact and develop in their careers
Drive the team's recruiting efforts, including hiring planning, process improvements, and sourcing and closing
Help identify and support opportunities for collaboration with other teams across Anthropic
Communicate team updates and results to other teams and leadership
Maintain a deep understanding of the team's technical work and its implications for AI safety
You may be a good fit if you
Are an experienced manager (minimum 2-5 years) with a track record of effectively leading highly technical research and/or engineering teams
Have a background in machine learning, AI, or a related technical field
Actively enjoy people management and are experienced with coaching and mentorship, performance evaluation, career development, and hiring for technical roles
Have strong project management skills, including prioritization and cross-functional coordination and collaboration
Have managed technical teams through periods of ambiguity and change
Are a quick learner, capable of understanding and contributing to discussions on complex technical topics and are motivated to learn about our research
Are a strong communicator both in speaking and in writing
Believe that advanced AI systems could have a transformative effect on the world, and are passionate about helping make sure that transformation goes well
Strong candidates may also have
Experience scaling engineering infrastructure
Experience working on open-ended, exploratory research agendas aimed at foundational insights
Some familiarity with our work and mechanistic interpretability
Role-Specific Location Policy
This role is expected to be in our SF office for 3 days a week.
The annual compensation range for this role is listed below.
For sales roles, the range provided is the role’s On Target Earnings ("OTE") range, meaning that the range includes both the sales commissions/sales bonuses target and annual base salary for the role.
Annual Salary:
$350,000
—
$500,000 USD
Logistics
Minimum education:
Bachelor’s degree or an equivalent combination of education, training, and/or experience
Required field of study:
A field relevant to the role as demonstrated through coursework, training, or professional experience
Minimum years of experience:
Years of experience required will correlate with the internal job level requirements for the position
Location-based hybrid policy:
Currently, we expect all staff to be in one of our offices at least 25% of the time. However, some roles may require more time in our offices.
Visa sponsorship:
We do sponsor visas! However, we aren't able to successfully sponsor visas for every role and every candidate. But if we make you an offer, we will make every reasonable effort to get you a visa, and we retain an immigration lawyer to help with this.
For roles performing work in California:
We will consider for employment all qualified applicants, including those with arrest or conviction records or criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the San Francisco Fair Chance Ordinance, the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance, the Los Angeles County Fair Chance Ordinance for Employers, and the California Fair Chance Act.
We encourage you to apply even if you do not believe you meet every single qualification.
Not all strong candidates will meet every single qualification as listed. Research shows that people who identify as being from underrepresented groups are more prone to experiencing imposter syndrome and doubting the strength of their candidacy, so we urge you not to exclude yourself prematurely and to submit an application if you're interested in this work. We think AI systems like the ones we're building have enormous social and ethical implications. We think this makes representation even more important, and we strive to include a range of diverse perspectives on our team.
Your safety matters to us.
To protect yourself from potential scams, remember that Anthropic recruiters only contact you from @anthropic.com email addresses. In some cases, we may partner with vetted recruiting agencies who will identify themselves as working on behalf of Anthropic. Be cautious of emails from other domains. Legitimate Anthropic recruiters will never ask for money, fees, or banking information before your first day. If you're ever unsure about a communication, don't click any links—visit
anthropic.com/careers
directly for confirmed position openings.
How we're different
We believe that the highest-impact AI research will be big science. At Anthropic we work as a single cohesive team on just a few large-scale research efforts. And we value impact — advancing our long-term goals of steerable, trustworthy AI — rather than work on smaller and more specific puzzles. We view AI research as an empirical science, which has as much in common with physics and biology as with traditional efforts in computer science. We're an extremely collaborative group, and we host frequent research discussions to ensure that we are pursuing the highest-impact work at any given time. As such, we greatly value communication skills.
The easiest way to understand our research directions is to read our recent research. This research continues many of the directions our team worked on prior to Anthropic, including: GPT-3, Circuit-Based Interpretability, Multimodal Neurons, Scaling Laws, AI & Compute, Concrete Problems in AI Safety, and Learning from Human Preferences.
Come work with us!
Anthropic is a public benefit corporation headquartered in San Francisco. We offer competitive compensation and benefits, optional equity donation matching, generous vacation and parental leave, flexible working hours, and a lovely office space in which to collaborate with colleagues.
Guidance on Candidates' AI Usage:
Learn about
our policy
for using AI in our application process.
Location: San Francisco, CA
About Anthropic
Anthropic’s mission is to create reliable, interpretable, and steerable AI systems. We want AI to be safe and beneficial for our users and for society as a whole. Our team is a quickly growing group of committed researchers, engineers, policy experts, and business leaders working together to build beneficial AI systems.
About the role:
When you see what modern language models are capable of, do you wonder, "How do these things work? How can we trust them?"
The Interpretability team at Anthropic is working to reverse-engineer how trained models work because we believe that a mechanistic understanding is the most robust way to make advanced systems safe.
Think of us as doing "neuroscience" of neural networks using "microscopes" we build - or reverse-engineering neural networks like binary programs.
More resources to learn about our work:
Our research blog
- covering advances including
Monosemantic Features
and
Circuits
An Introduction to Interpretability
from our research lead,
Chris Olah
The Urgency of Interpretability
from CEO Dario Amodei
Engineering Challenges Scaling Interpretability
- directly relevant to this role
60 Minutes
segment - Around 8:07, see a demo of tooling our team built
New Yorker
article - what it's like to work on one of AI's hardest open problems
Even if you haven’t worked on interpretability before, the infrastructure expertise is similar to what's needed across the lifecycle of a production language model:
Pretraining: Training dictionary learning models looks a lot like model pretraining - creating stable, performant training jobs for massively parameterized models across thousands of chips
Inference: Interp runs a customized inference stack. Day-to-day analysis requires services that allow editing a model's internal activations mid-forward-pass - for example, adding a "steering vector"
Performance: Like all LLM work, we push up against the limits of hardware and software. Rather than squeezing the last 0.1%, we are focused on finding bottlenecks, fixing them and moving ahead given rapidly evolving research and safety mission
The science keeps scaling - and it's now applied directly in
safety audits
on frontier models, with real deadlines. As our research has matured, engineering and infrastructure have become a bottleneck. Your work will have a direct impact on one of the most important open problems in AI.
Responsibilities:
Build and maintain the specialized inference and training infrastructure that powers interpretability research - including instrumented forward/backward passes, activation extraction, and steering vector application
Resolve scaling and efficiency bottlenecks through profiling, optimization, and close collaboration with peer infrastructure teams
Design tools, abstractions, and platforms that enable researchers to rapidly experiment without hitting engineering barriers
Help bring interpretability research into production safety audits - with real deadlines and high reliability expectations
Work across the stack - from model internals and accelerator-level optimization to user-facing research tooling
You may be a good fit if you:
Have 5-10+ years of experience building software
Are highly proficient in at least one programming language (e.g., Python, Rust, Go, Java) and productive with Python
Are extremely curious about unfamiliar domains; can quickly learn and put that knowledge to work, e.g. diving into new layers of the stack to find bottlenecks
Have a strong ability to prioritize the most impactful work and are comfortable operating with ambiguity and questioning assumptions
Prefer fast-moving collaborative projects to extensive solo efforts
Are curious about interpretability research and its role in AI safety (though no research experience is required!)
Care about the societal impacts and ethics of your work
Are comfortable working closely with researchers, translating research needs into engineering solutions.
Strong candidates may also have experience with:
Optimizing the performance of large-scale distributed systems
Language modeling fundamentals with transformers
High Performance LLM optimization: memory management, compute efficiency, parallelism strategies, inference throughput optimization
Working hands-on in a mainstream ML stack - PyTorch/CUDA on GPUs or JAX/XLA on TPUs
Collaborating closely with researchers and building tooling to support research teams; or directly performed research with complex engineering challenges
Representative Projects:
Building
Garcon
, a tool that allows researchers to easily instrument LLMs to extract internal activations
Designing and optimizing a pipeline to efficiently collect petabytes of transformer activations and shuffle them
Profiling and optimizing ML training jobs, including multi-GPU parallelism and memory optimization
Building a steered inference system that applies targeted interventions to model internals at scale (conceptually similar to
Golden Gate Claude
but for safety research)
Role Specific Location Policy:
This role is based in the San Francisco office; however, we are open to considering exceptional candidates for remote work on a case-by-case basis.
The annual compensation range for this role is listed below.
For sales roles, the range provided is the role’s On Target Earnings ("OTE") range, meaning that the range includes both the sales commissions/sales bonuses target and annual base salary for the role.
Annual Salary:
$315,000
—
$560,000 USD
Logistics
Minimum education:
Bachelor’s degree or an equivalent combination of education, training, and/or experience
Required field of study:
A field relevant to the role as demonstrated through coursework, training, or professional experience
Minimum years of experience:
Years of experience required will correlate with the internal job level requirements for the position
Location-based hybrid policy:
Currently, we expect all staff to be in one of our offices at least 25% of the time. However, some roles may require more time in our offices.
Visa sponsorship:
We do sponsor visas! However, we aren't able to successfully sponsor visas for every role and every candidate. But if we make you an offer, we will make every reasonable effort to get you a visa, and we retain an immigration lawyer to help with this.
For roles performing work in California:
We will consider for employment all qualified applicants, including those with arrest or conviction records or criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the San Francisco Fair Chance Ordinance, the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance, the Los Angeles County Fair Chance Ordinance for Employers, and the California Fair Chance Act.
We encourage you to apply even if you do not believe you meet every single qualification.
Not all strong candidates will meet every single qualification as listed. Research shows that people who identify as being from underrepresented groups are more prone to experiencing imposter syndrome and doubting the strength of their candidacy, so we urge you not to exclude yourself prematurely and to submit an application if you're interested in this work. We think AI systems like the ones we're building have enormous social and ethical implications. We think this makes representation even more important, and we strive to include a range of diverse perspectives on our team.
Your safety matters to us.
To protect yourself from potential scams, remember that Anthropic recruiters only contact you from @anthropic.com email addresses. In some cases, we may partner with vetted recruiting agencies who will identify themselves as working on behalf of Anthropic. Be cautious of emails from other domains. Legitimate Anthropic recruiters will never ask for money, fees, or banking information before your first day. If you're ever unsure about a communication, don't click any links—visit
anthropic.com/careers
directly for confirmed position openings.
How we're different
We believe that the highest-impact AI research will be big science. At Anthropic we work as a single cohesive team on just a few large-scale research efforts. And we value impact — advancing our long-term goals of steerable, trustworthy AI — rather than work on smaller and more specific puzzles. We view AI research as an empirical science, which has as much in common with physics and biology as with traditional efforts in computer science. We're an extremely collaborative group, and we host frequent research discussions to ensure that we are pursuing the highest-impact work at any given time. As such, we greatly value communication skills.
The easiest way to understand our research directions is to read our recent research. This research continues many of the directions our team worked on prior to Anthropic, including: GPT-3, Circuit-Based Interpretability, Multimodal Neurons, Scaling Laws, AI & Compute, Concrete Problems in AI Safety, and Learning from Human Preferences.
Come work with us!
Anthropic is a public benefit corporation headquartered in San Francisco. We offer competitive compensation and benefits, optional equity donation matching, generous vacation and parental leave, flexible working hours, and a lovely office space in which to collaborate with colleagues.
Guidance on Candidates' AI Usage:
Learn about
our policy
for using AI in our application process.
Location: Brazil
Job Description
Job Title: Medical Reviewer
Employment Type: Contract
Location: Brazil
Experience – 2 to 5 Years
About ClinChoice
ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis.
Our global delivery network has expanded to centres and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally.
We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.
Primary Responsibilities:
Awareness and understanding of relevant GVP modules.
Perform medical review of non-serious & serious ICSRs with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance.
Experience of medical review of ICSRs received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials.
Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases etc.
Support triage of cases and determine seriousness and relatedness across products as assigned.
Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling and review narrative.
Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas.
Involve in process improvement activities such as implementation of quality control process.
Provide medical guidance and expert opinion on the cases to the data entry associates and quality reviewers to help resolve queries.
Identify and resolve case issues, coordinate with client therapeutic teams and within functional team and manage as appropriate.
Maintain PV expertise, and understanding of international safety regulations and guidelines.
Responsible for completing the MR activities in the safety database within the stipulated time to comply with service level agreements and regulatory timelines.
Provide timely feedback to case processors on the errors/ discrepancies noted.
Assist in training/mentoring of other case processing/medical review personnel as necessitated.
Adapt to different client case processing conventions and multi-task as per business needs.
Perform ad-hoc tasks as advised by the team lead/manager with quality and compliance as per project requirement.
Participate in organizational activities to meet objectives suitable for the role/area of expertise.
Candidate Profile:
Should be a MBBS/MD with at least 2 years of experience as Medical Reviewer for ICSRs.
Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements.
Training and mentoring skill (GVP concepts & medical aspects such as disease condition, product portfolio etc)
Must have hands on experience with MS Office applications (Outlook, Excel, Word, Power Point etc)
Must be able to Write and speak Japanese.
Dynamic working hours.
San Francisco, CA
San Francisco, CA
Не хотите искать каждый день?
Настройте подбор один раз, и подходящие вакансии будут сами приходить в Telegram.
Настройте подбор, и подходящие вакансии будут приходить в Telegram.