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

Icon Plc
ICON PLC
2-4 years
Not Disclosed
Pune, India
1 May 7, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Labelling Assessment, MedDRA Coding, Medical Billing, 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 Pune | Syneos Health Careers

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


About Syneos Health

Syneos Health is a globally recognized biopharmaceutical solutions organization that supports pharmaceutical, biotechnology, and healthcare companies throughout the drug development and commercialization lifecycle. The company specializes in clinical research, pharmacovigilance, regulatory affairs, and medical solutions that help accelerate patient-focused healthcare innovations.

With a strong global presence and expertise in clinical operations and safety management, Syneos Health provides professionals with opportunities to work on high-impact healthcare and drug safety projects worldwide.


Job Overview

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

The role is focused on:

  • ICSR Case Processing
  • Pharmacovigilance Operations
  • Adverse Event Reporting
  • Safety Database Management
  • MedDRA Coding
  • Regulatory Compliance

Candidates with prior experience in post-marketing pharmacovigilance and clinical safety operations will have an advantage.


Experience Required

Required Experience

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

Mandatory Experience

Candidates must have experience handling:

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

Freshers Eligibility

  • Freshers are not eligible
  • Prior pharmacovigilance experience is mandatory

Educational Qualification

Candidates should possess:

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

OR

  • Equivalent relevant experience in Pharmacovigilance or Drug Safety

Key Responsibilities

ICSR Case Processing

  • Process Individual Case Safety Reports (ICSRs)
  • Perform case triage and safety data review
  • Evaluate case completeness, accuracy, and reportability
  • Enter data into safety databases

Safety Coding & Medical Review

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

Narrative Writing & Query Management

  • Prepare complete narrative summaries
  • Identify missing safety information
  • Follow up for query resolution and case completion

Regulatory Compliance

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

Advanced Pharmacovigilance Activities

  • xEVMPD Product Validation & Submission
  • SPOR / IDMP Activities
  • Duplicate ICSR Identification & Management
  • Quality Review of Safety Cases

Documentation & Audit Support

  • Maintain Trial Master File (TMF) documentation
  • Participate in audits and compliance activities
  • Follow SOPs, Work Instructions, and project safety plans