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 advantage-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
Solid 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

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