Job Location: PAN INDIA - Mumbai, Pune, Bangalore, Noida

Work Model: Work from Office / Hybrid

Candidate Expectations

Total and Relevant Experience 3 Years to 7 Years

Diversity No

Education and Certification - Qualification: (MBBS/MD) / Life Science Graduate

Specific Remarks:
Distance education not accepted.

Certification: MCI added advantage

- Detailed Job Description
- Perform signal detection, evaluation, and risk assessment for assigned products
- Deliver fit-for-purpose safety evaluations with transparent conclusions for internal and regulatory stakeholders.
- Contribute to protocols, program documents, and safety governance activities
- Identify, assess, and escalate safety signals/issues with recommended risk mitigation strategies
- Support health authority responses, audits, and inspection readiness activities
- Drive process improvements and ensure compliance with ICH, GVP, and global PV regulations
- Collaborate within cross-functional matrix teams and manage multiple deliverables with quality and timelines




- Provide Medical inputs on pharmacovigilance and risk management planning; contribute to benefit risk assessments and Risk Management Plans (RMPs)
- Drive signal detection, evaluation, and labeling recommendations using safety databases and literature
- Author and review aggregate safety reports (PSUR/PBRER, Annual Reports) and regulatory submissions
- Provide medical oversight for protocols, investigator brochures, informed consents, study reports, and safety governance forums
- Evaluate and escalate safety signals/issues; recommend risk mitigation strategies and labeling updates
- Collaborate with cross-functional teams (Clinical, Regulatory, Product Scientists) for safety decision-making
- Ensure inspection readiness, audit compliance, and adherence to global PV regulations (ICH, GVP).

Key Skills

Signal detection, evaluation, and risk assessment.

Other Specific Remarks / Additional Requirements: Proper documents for entire career and PF Form 16 Mandatory .

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