SERM Physician / Scientist - Sr. Associate

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 clear 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 .