Job Description We're Hiring | SERM Physician (Safety Evaluation & Risk Management)
n Are 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.
n Eligibility Criteria
n •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
n Key Responsibilities
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/PBRER
n • 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 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 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 Report Authoring & 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 Guidelines
n • 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.
n Interested candidates can share at &
n If 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.

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