Syneos Health, a leading global biopharmaceutical solutions organization, is hiring Safety & Pharmacovigilance (PV) Specialist I professionals for its Pune and Hyderabad locations. These full-time, office-based roles are ideal for life science, pharmacy, and healthcare graduates aspiring to build a career in pharmacovigilance.
With Syneos Health involved in 94% of all novel FDA-approved drugs in the last five years, joining this team gives you direct exposure to global clinical development and post-marketing safety.
Key Responsibilities
As a Safety & PV Specialist, you will:
- Enter and track ICSR data in PVG systems
- Process ICSRs as per SOPs and project-specific safety plans
- Perform triage, assess completeness and regulatory reportability
- Enter safety data and perform MedDRA coding
- Write narrative summaries and resolve queries
- Perform literature screening, drug coding, and maintain drug dictionaries
- Conduct quality review of ICSRs
- Identify duplicates and perform recoding activities
- Handle SPOR/IDMP activities
- Validate and submit xEVMPD product records
- Maintain TMF documentation for clinical trials
- Follow GCP, GVP, ICH, and regulatory guidelines
- Participate in audits and cross-functional collaborations
These responsibilities provide hands-on exposure to global pharmacovigilance workflows.
Qualifications Required
Candidates must have:
- Bachelor’s Degree in Life Science, Pharmacy, Medical, Nursing, or equivalent
- Knowledge of medical terminology & safety database systems
- Understanding of ICH GCP, GVP, and clinical trial processes
- Strong communication skills
- Detail orientation & ability to handle multiple tasks
- Proficiency in MS Office tools
Experience in PV is preferred but not always mandatory for strong life science candidates.
Why Work at Syneos Health?
Syneos Health offers:
- Global exposure with top pharmaceutical clients
- Career growth opportunities & structured training
- Total Self culture promoting diversity, inclusion, and well-being
- Supportive leadership and peer recognition
- Work that directly contributes to patient safety
Job Locations
- Pune
- Hyderabad (office-based)
Both positions offer excellent opportunities for professionals looking to build a long-term career in drug safety and pharmacovigilance.
How to Apply
Application Link for Safety & PV Specialist I – Req ID 25102728 (Pune/Hyderabad)
Application Link for Safety & PV Specialist I – Req ID 25103019 (Pune)
