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Safety & Pv Specialist I – Pharmacovigilance

Syneos Health
Syneos Health
2-4 years
Not Disclosed
Hyderabad
2 May 11, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding

Safety & PV Specialist I – Pharmacovigilance & ICSR Case Processing

Company: Syneos Health
Job Title: Safety & PV Specialist I
Location: Hyderabad, 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 team in Hyderabad. This role is designed for professionals experienced in ICSR Case Processing, Post-Marketing Pharmacovigilance, MedDRA Coding, Literature Review, and Regulatory Safety Reporting.

The selected candidate will contribute to global pharmacovigilance operations by handling safety case processing, narrative writing, expedited reporting, duplicate case management, literature screening, and compliance with international pharmacovigilance regulations.

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


Key Responsibilities

ICSR Processing & Drug Safety Operations

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

Medical Coding & Narrative Writing

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

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 safety reporting regulatory intelligence to support global safety operations

Advanced Pharmacovigilance Activities

  • Validate and submit xEVMPD product records
  • Perform manual recoding of un-recoded product and substance terms from ICSRs
  • Identify and manage duplicate ICSRs
  • Support SPOR / IDMP-related activities
  • Conduct quality review of safety cases and reports

Documentation & Clinical Trial Support

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

Educational Qualification

Candidates should possess:

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

OR equivalent education and relevant pharmacovigilance experience.


Required Experience

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

Mandatory Requirement

  • Post-Marketing Case Processing experience is mandatory