SERM Physician

Position: Safety Evaluation & Risk Management (SERM Physician) Location: PAN India Experience: 5+ Years Salary: Up to 25 LPA Employment Type: Full-time Degree : MBBS / MD Industry : Life Sciences Key Responsibilities - Provide medical expertise in Pharmacovigilance activities, including benefit-risk evaluation and safety strategy. - Lead signal detection, signal validation, and signal evaluation using safety databases, clinical data, and scientific literature to identify emerging safety concerns. - Author, review, and provide medical oversight for aggregate safety reports, including: - PSUR/PBRER - Annual Safety Reports - Regulatory safety submissions - Develop, review, and contribute to Risk Management Plans (RMPs), ensuring appropriate risk minimization strategies throughout the product lifecycle. - Evaluate safety signals and adverse event trends, recommending appropriate risk mitigation measures, labeling updates, and regulatory actions when required. - Provide medical review and oversight for: - Clinical Study Protocols - Investigator Brochures (IB) - Informed Consent Forms (ICF) - Clinical Study Reports (CSR) - Safety governance documentation - Collaborate closely with cross-functional global teams, including Clinical Development, Regulatory Affairs, Medical Affairs, Product Scientists, and Pharmacovigilance stakeholders to support informed safety decisions. - Ensure inspection readiness by maintaining compliance with global Pharmacovigilance regulations, including ICH Guidelines and GVP Modules. Mandatory hands-on experience in: - Aggregate Safety Report Authoring & Review (PSUR/PBRER, Annual Reports) - Signal Detection & Signal Evaluation - Strong understanding of: - Benefit-Risk Assessment - Risk Management Plans (RMP) - Global Pharmacovigilance regulations - ICH Guidelines - GVP Modules - Regulatory safety reporting requirements - Excellent analytical, medical writing, stakeholder management, and communication skills. - Experience working within global cross-functional matrix organizations will be highly preferred. 📩 Interested candidates can share at gaurangna@latinumhr.com & jobs@ats.latinumhr.com