Job DescriptionWe're Hiring | SERM Physician (Safety Evaluation & Risk Management) NAre you passionate about Drug Safety, Pharmacovigilance, and Medical Risk Assessment? We are looking for an experienced SERM Physician to join our global Pharmacovigilance team and play a critical role in ensuring patient safety throughout the product lifecycle. NEligibility Criterian
- Position: SERM Physician N
- Location: PAN India N
- Experience: 5+ Years N
- Salary: Up to 35 LPA (Depending on Exp) N
- Employment Type: Full time N
- Degree: MBBS / MD NKey Responsibilitiesn
- 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
- Mandatory hands-on experience in: N
- Aggregate Safety ReportAuthoring & Review (PSUR/PBRER, Annual Reports) N
- Signal Detection & Signal Evaluation N
- Strong 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
- Excellent analytical, medical writing, stakeholder management, and communication skills. N
- Experience working within global cross-functional matrix organizations will be highly preferred. NInterested candidates canshare at [email protected] & [email protected] NIf this opportunity matches your expertise—or you know someone who would be a great fit—please feel free to connect or share this post within your network.

📌 Serm Physician (Alibag)
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