Safety Evaluation & Risk Management

Position: SERM Physician

Location: PAN India

Experience: 5+ Years

Salary: Up to 25 LPA

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), (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
- Solid 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]

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