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Safety & Pv Specialist I – Pharmacovigilance & Drug Safety Jobs In Hyderabad | Syneos Health

Syneos Health
Syneos Health
2-4 years
Not Disclosed
Hyderabad
1 May 7, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: 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 & Drug Safety Jobs in Hyderabad | Syneos Health

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

Source:


About Syneos Health

Syneos Health is a globally recognized integrated biopharmaceutical solutions organization that supports pharmaceutical, biotechnology, and healthcare companies across the drug development lifecycle. The company provides expertise in clinical development, commercialization, pharmacovigilance, regulatory affairs, and medical affairs.

With operations across multiple countries, Syneos Health partners with leading innovators to accelerate drug development, improve patient outcomes, and support global healthcare advancements.


Job Overview

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

This role is ideal for professionals experienced in:

  • ICSR Case Processing
  • Post-Marketing Pharmacovigilance
  • Clinical Trial Safety Operations
  • Drug Safety Data Management
  • MedDRA Coding
  • Safety Database Management

The selected candidate will support global pharmacovigilance activities including adverse event processing, literature review, safety reporting, duplicate management, and regulatory compliance activities.


Experience Required

Required Experience

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

Mandatory Experience

  • Post-Marketing Case Processing experience is mandatory
  • Experience handling:
    • Spontaneous Cases
    • Clinical Trial Cases
    • Literature Cases

Freshers Eligibility

  • Freshers are NOT eligible
  • Prior pharmacovigilance experience is required

Source:


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 triaging and data validation
  • Evaluate case completeness, accuracy, and reportability
  • Enter safety data into pharmacovigilance databases

Safety Coding & Data Review

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

Narrative Writing & Query Management

  • Prepare narrative summaries for adverse event cases
  • Identify missing information and follow up for resolution

Regulatory Compliance

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

Safety Database Activities

  • Perform:
    • Duplicate ICSR Management
    • xEVMPD Product Record Validation
    • SPOR / IDMP related activities
    • Safety tracking and documentation

Quality & Audit Support

  • Conduct quality review of ICSRs
  • Participate in audits and compliance activities
  • Ensure timely filing of documents in TMF and PV System Master File