Safety Evaluation & Risk Management

Position: SERM Physician
Location: PAN India
Experience: 5+ Years
Salary: Up to 30 LPA
Degree : B.Pharm/D.Pharm/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), (CSR)




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
Robust 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]

📌 SERM Physician (Vasanthanagar)
🏢 Latinum Hr Solutions
📍 Vasanthanagar