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
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 advantage 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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