SERM Physician / Scientist - Sr Associate

Location: Pune, Bengaluru, Noida, Mumbai   •   Experience: Mid Level   •   Openings: 2
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Job description

Job Details
Job Title: SERM Physician / Scientist
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
Candidate Location - Anywhere
Skills – signal detection, evaluation, and risk assessment
Candidate Industry (Pharma)
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