Job DescriptionPosition: Safety Evaluation & Risk Management (SERM Physician)
nLocation: PAN India
nExperience: 5+ Years
nSalary: Up to 25 LPA
nEmployment Type: Full time
nDegree : MBBS / MD
nIndustry : Life Sciences
nKey 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
- PSUR/PBRERn
- Annual Safety Reportsn
- Regulatory safety submissionsn
- 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




- Clinical Study Protocolsn
- Investigator Brochures (IB)n
- Informed Consent Forms (ICF)n
- Clinical Study Reports (CSR)n
- Safety governance documentationn
- 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

nMandatory hands-on experience in:
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- Aggregate Safety Report Authoring & Review (PSUR/PBRER, Annual Reports)n
- Signal Detection & Signal Evaluationn
- Strong understanding of:n
- Benefit-Risk Assessmentn
- Risk Management Plans (RMP)n
- Global Pharmacovigilance regulationsn
- ICH Guidelinesn
- GVP Modulesn
- Regulatory safety reporting requirementsn
- Excellent analytical, medical

📌 SERM Physician (Pune)
🏢 Latinum Hr Solutions
📍 Pune