SERM Physician

Latinum HR Solutions · India

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/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 gaurangna@latinumhr.com & jobs@ats.latinumhr.com