Job Description
Safety Evaluation & Risk Management
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n Position: SERM Physician
n Location: PAN India
n Experience: 5+ Years
n Salary: Up to 30 LPA
n Degree : B.Pharm/D.Pharm/MBBS/MD
n Industry : Life Sciences
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n Key Responsibilities
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- Provide medical expertise in Pharmacovigilance activities, including benefit-risk evaluation and safety strategy.n
- Lead signal detection, signal validation, and signal evaluation using safety databases, clinical data, and scientific literature to identify emerging safety concerns.n
- Author, review, and provide medical oversight for aggregate safety reports, including:n

nPSUR/PBRER , Annual Safety Reports, Regulatory safety submissions
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- Develop, review, and contribute to Risk Management Plans (RMPs), ensuring appropriate risk minimization strategies throughout the product lifecycle.n
- Evaluate safety signals and adverse event trends, recommending appropriate risk mitigation measures, labeling updates, and regulatory actions when required.n
- Provide medical review and oversight for:n





nClinical Study Protocols, Investigator Brochures (IB), Informed Consent Forms (ICF), (CSR)
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- Collaborate closely with cross-functional global teams, including Clinical Development, Regulatory Affairs, Medical Affairs, Product Scientists, and Pharmacovigilance stakeholders to support informed safety decisions.n
- Ensure inspection readiness by maintaining compliance with global Pharmacovigilance regulations, including ICH Guidelines and GVP Modules.n

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n Mandatory hands-on experience in:
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- Aggregate Safety Report Authoring & Review (PSUR/PBRER, Annual Reports)n
- Signal Detection & Signal Evaluationn
- Robust understanding of: Benefit-Risk Assessment, Risk Management Plans (RMP), Global Pharmacovigilance regulations, ICH Guidelines, GVP Modulesn
- Regulatory safety reporting requirementsn
- Excellent analytical, medical writing, stakeholder management, and communication skills.n
- Experien

📌 SERM Physician (Bengaluru)
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