We're Hiring | SERM Physician (Safety Evaluation & Risk Management) 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.

Eligibility

Criteria •Position: SERM Physician • Location: PAN India • Experience: 5+ Years • Salary: Up to 35 LPA (Depending on Exp) • Employment Type: Full-time • Degree : MBBS / MD 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 [email protected] & [email protected] If this prospect 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 (Vasanthanagar)
🏢 Latinum Hr Solutions
📍 Vasanthanagar