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Safety & Pv Specialist I – Pharmacovigilance & Icsr Case Processing

Syneos Health
Syneos Health
2-4 years
Not Disclosed
Pune, India
2 May 11, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. 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: Pune, India
Job ID: 25107802
Department: Clinical Solutions / Pharmacovigilance


About the Role

Syneos Health is hiring a Safety & PV Specialist I for its Pharmacovigilance and Drug Safety operations team in Pune. This opportunity is ideal for professionals with experience in ICSR Case Processing, Post-Marketing Pharmacovigilance, Literature Screening, MedDRA Coding, and Safety Reporting.

The selected candidate will support global pharmacovigilance activities including safety case processing, regulatory reporting, literature review, duplicate management, quality review, and compliance with international safety regulations.

This role is best suited for candidates with 2–4 years of Pharmacovigilance and ICSR processing experience.


Key Responsibilities

ICSR Case Processing & Safety Operations

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

Medical Coding & Narrative Writing

  • Perform:
    • MedDRA coding
    • Drug coding
    • Medical history coding
    • Concomitant medication coding
    • Test coding
  • Prepare complete and accurate narrative summaries
  • Identify missing information and perform query follow-up activities
  • Support literature screening and safety review activities

Regulatory Compliance & Reporting

  • Assist in generation of expedited safety reports in compliance with global regulatory requirements
  • Maintain compliance with:
    • ICH Guidelines
    • GCP
    • GVP
    • Global safety regulations
  • Participate in audits and quality review activities
  • Apply safety reporting regulatory intelligence to safety operations

Advanced Pharmacovigilance Activities

  • Perform validation and submission of xEVMPD product records
  • Conduct manual recoding of product and substance terms from ICSRs
  • Identify and manage duplicate ICSRs
  • Support SPOR / IDMP-related activities
  • Perform quality review of ICSRs

Documentation & Trial Support

  • Ensure proper documentation submission to:
    • Trial Master File (TMF)
    • Pharmacovigilance System Master File
  • Maintain understanding of:
    • Drug development processes
    • Clinical trial safety requirements
    • Post-marketing pharmacovigilance standards

Educational Qualification

Candidates should possess:

  • Bachelor’s Degree in:
    • Life Sciences
    • Pharmacy
    • Nursing
    • Related healthcare field

OR equivalent education and relevant pharmacovigilance experience.


Required Experience

  • 2 to 4 years of experience in:
    • ICSR Case Processing
    • Pharmacovigilance Operations
    • Drug Safety
    • Post-Marketing Case Processing
    • Literature Case Handling

Mandatory Requirement

  • Post-Marketing Case Processing experience is mandatory