19 Oct
|
Jobgether
|
India
This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Physician, Patient Safety based in India.
The Senior Physician, Patient Safety will provide medical expertise and oversight across pharmacovigilance activities for investigational and marketed products, helping protect patients throughout the product lifecycle. You will evaluate adverse event reports, assess safety signals, and contribute to benefit-risk assessments to support informed medical and regulatory decisions. Working closely with pharmacovigilance teams, clients, and cross-functional stakeholders, you will help ensure safety information is accurate, consistent, and compliant with international requirements. The role includes reviewing and authoring safety documentation, supporting regulatory submissions, and contributing to risk management strategies. You will also provide medical guidance to colleagues, support audits and inspection readiness, and help improve operational processes.
This remote opportunity offers the chance to apply your clinical expertise across diverse therapeutic programs while contributing to patient safety and the development of creative therapies.
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Accountabilities
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Conduct medical review and assessment of individual case safety reports involving adverse events and adverse reactions associated with investigational and marketed products.
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Evaluate case causality, seriousness, and expectedness, providing medical guidance to case processing teams and pharmacovigilance specialists.
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Perform signal detection, analysis, evaluation, and ongoing safety surveillance, including tracking potential signals and communicating findings to relevant stakeholders.
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Review, prepare, and contribute to aggregate safety reports and regulatory documents, including PSURs, PBRERs, PADERS, Risk Management Plans, Benefit-Risk Assessments, Safety Evaluation Reports, Clinical Overviews, Clinical Expert Stateme
📌 Senior Physician, Patient Safety (India)
🏢 Jobgether
📍 India