01Overview
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/PBRERAnnual Safety ReportsRegulatory safety submissionsDevelop, 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 ProtocolsInvestigator Brochures (IB)Informed Consent Forms (ICF)Clinical Study Reports (CSR)Safety governance documentationCollaborate 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 EvaluationStrong understanding of:Benefit-Risk AssessmentRisk Management Plans (RMP)Global Pharmacovigilance regulationsICH GuidelinesGVP ModulesRegulatory safety reporting requirementsExcellent 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 .
