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Safety & Pv Specialist I – Pharmacovigilance & Icsr Case Processing

Syneos Health
Syneos Health
2-4 years
Not Disclosed
Gurgaon, India
2 May 11, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Safety & PV Specialist I – Pharmacovigilance & ICSR Case Processing

Company: Syneos Health
Job Title: Safety & PV Specialist I
Location: Gurugram, India
Job ID: 25107802
Department: Clinical Solutions / Pharmacovigilance


About the Role

Syneos Health is seeking a Safety & PV Specialist I to join its Pharmacovigilance and Drug Safety team in Gurugram. This role is ideal for professionals with experience in ICSR Case Processing, Post-Marketing Pharmacovigilance, MedDRA Coding, Literature Review, and Regulatory Safety Reporting.

The selected candidate will support end-to-end pharmacovigilance operations, including case triage, narrative writing, expedited reporting, duplicate management, quality review, and compliance with global safety regulations and reporting standards.

This opportunity is suitable for candidates with 2–4 years of Pharmacovigilance and ICSR processing experience.


Key Responsibilities

ICSR Processing & Safety Operations

  • Enter and maintain safety data in Pharmacovigilance tracking systems
  • Process Individual Case Safety Reports (ICSRs) according to SOPs and safety plans
  • Perform ICSR triage and evaluate cases for:
    • Accuracy
    • Completeness
    • Regulatory reportability
  • Enter case data into safety databases
  • Maintain tracking and documentation for assigned safety activities

Medical Coding & Narrative Development

  • Perform:
    • MedDRA coding
    • Drug coding
    • Medical history coding
    • Concomitant medication coding
    • Test result coding
  • Prepare complete narrative summaries for safety cases
  • Identify missing information and conduct follow-up queries until resolution
  • Support literature screening and review activities for safety reporting

Regulatory Compliance & Reporting

  • Assist in preparing expedited safety reports within regulatory timelines
  • Ensure compliance with:
    • ICH Guidelines
    • GCP
    • GVP
    • Global Pharmacovigilance regulations
  • Participate in audits and quality review activities
  • Apply regulatory intelligence to support pharmacovigilance operations