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

📌 Safety Physician (Pune)
🏢 Latinum Hr Solutions
📍 Pune