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.

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📌 SERM Physician (Vasanth Nagar)
🏢 Latinum Hr Solutions
📍 Vasanth Nagar