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Safety & Pv Specialist I – Pharmacovigilance Jobs In Gurugram | Syneos Health Careers

Syneos Health
Syneos Health
2-4 years
Not Disclosed
Gurugram, India
1 May 7, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Safety & PV Specialist I – Pharmacovigilance Jobs in Gurugram | Syneos Health Careers

Company: Syneos Health
Job Title: Safety & PV Specialist I
Location: Gurugram, India
Job Type: Full-Time
Industry: Pharmacovigilance, Drug Safety, Clinical Research
Job ID: 25107802

Source:


About Syneos Health

Syneos Health is a leading global biopharmaceutical solutions organization that supports pharmaceutical, biotechnology, and healthcare companies across clinical development and commercialization. The company partners with life sciences innovators to accelerate drug development, improve regulatory outcomes, and support patient safety worldwide.

With a strong presence in clinical research, pharmacovigilance, medical affairs, and regulatory services, Syneos Health offers professionals an opportunity to work on global healthcare and drug safety projects.


Job Overview

Syneos Health is hiring a Safety & PV Specialist I for its Pharmacovigilance and Drug Safety team in Gurugram, India.

The role focuses on:

  • ICSR Case Processing
  • Adverse Event Management
  • Safety Database Operations
  • MedDRA Coding
  • Post-Marketing Pharmacovigilance
  • Regulatory Safety Reporting

This opportunity is ideal for professionals with prior experience in pharmacovigilance and clinical safety operations looking to build a long-term career in global drug safety and regulatory compliance.


Experience Required

Required Experience

  • Minimum 2 to 4 years of experience in:
    • ICSR Case Processing
    • Pharmacovigilance Operations
    • Drug Safety

Mandatory Experience

Candidates must have experience handling:

  • Post-Marketing Case Processing
  • Spontaneous Cases
  • Clinical Trial Safety Cases
  • Literature Cases

Freshers Eligibility

  • Freshers are not eligible
  • Prior pharmacovigilance experience is mandatory

Source:


Educational Qualification

Applicants should possess:

  • Bachelor’s Degree in:
    • Life Sciences
    • Pharmacy
    • Nursing
    • Healthcare-related field

OR

  • Equivalent relevant experience in Pharmacovigilance or Drug Safety Operations

Key Responsibilities

ICSR Processing

  • Process Individual Case Safety Reports (ICSRs)
  • Perform case intake, triage, and safety data review
  • Validate case completeness and regulatory reportability
  • Enter and maintain data in safety databases

Drug Safety & Coding Activities

  • Perform:
    • MedDRA Coding
    • Drug Dictionary Maintenance
    • Medical History Coding
    • Concomitant Medication Coding

Narrative Writing & Query Resolution

  • Prepare detailed case narratives
  • Follow up on missing or incomplete information
  • Resolve safety queries within timelines

Regulatory Safety Reporting

  • Support expedited reporting activities
  • Ensure compliance with:
    • ICH-GCP
    • GVP
    • Global Pharmacovigilance Regulations

Advanced Pharmacovigilance Activities

  • xEVMPD Product Record Validation & Submission
  • SPOR / IDMP activities
  • Duplicate ICSR Management
  • Quality review of safety cases

Documentation & Compliance

  • Maintain Trial Master File (TMF) documentation
  • Participate in audits and quality reviews
  • Follow SOPs, WIs, and safety reporting standards