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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- N
- 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 Reports N
- Regulatory safety submissions N
- Develop, review, and contribute to Risk Management Plans (RMPs), ensuring appropriate risk minimization strategies throughout the product lifecycle. N
- Evaluate safety signalsand 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 Protocols N
- Investigator Brochures (IB) N
- Informed Consent Forms (ICF) N
- Clinical Study Reports (CSR) N
- Safety governance documentation N
- 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-onexperience in:
N
- n
- Aggregate Safety Report Authoring & Review (PSUR/PBRER, Annual Reports) N
- Signal Detection & Signal Evaluation N
- Solid understanding of: N
- Benefit-Risk Assessment N
- Risk Management Plans (RMP) N
- Global Pharmacovigilance regulations N
- ICH Guidelinesn
- GVP Modules N
- Regulatory safety reporting requirements N
- E

📌 Serm Physician (India)
🏢 Latinum Hr Solutions
📍 India