Advertisement
If you’re looking for a pharmacovigilance career in India, Syneos Health—one of the world’s leading clinical research and biopharmaceutical organizations—is now hiring for two exciting full-time office-based positions:
- Safety Specialist I – Hyderabad
- Safety & PV Specialist II (Literature Review) – Hyderabad / Gurugram
These roles offer a great opportunity to work on global drug safety operations, exposure to ICH-GCP, GVP, ICSRs, MedDRA coding, and real-world safety databases while growing your PV career.
🧪 Role 1: Safety Specialist I – Hyderabad
Key Responsibilities
- Process and track Individual Case Safety Reports (ICSRs)
- Perform MedDRA coding, narrative writing, and query resolution
- Literature screening and drug coding
- Validate & submit xEVMPD product records
- Identify duplicate ICSRs and ensure regulatory reporting compliance
- Ensure proper documentation in Trial Master File (TMF)
- Support audits and maintain compliance with SOPs, GVP, ICH-GCP
Required Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or equivalent
- Understanding of pharmacovigilance regulations and safety reporting
- Knowledge of Safety Databases, MedDRA, GCP, GVP
- Strong communication, attention to detail & organizational skills
🧪 Role 2: Safety & PV Specialist II (Literature Review)
📍 Location: Hyderabad or Gurugram
Advertisement
Key Responsibilities
- Conduct global and local literature searches (Embase, PubMed, Medline)
- Extract and summarize safety-relevant data from publications
- Process literature-driven ICSRs and write narrative summaries
- Validate search strategies aligned with GVP Module VI
- Support audit readiness and TMF documentation compliance
- Collaborate with data management teams for reconciliation
Required Qualifications
- Bachelor’s/PG in Pharmacy, Life Science, Nursing, or equivalent
- Minimum 3.5+ years of pharmacovigilance experience
- Strong experience in literature review for safety case processing
- Mandatory knowledge of GVP Module VI
💼 Why Join Syneos Health?
- Career growth and mentorship
- Global project exposure
- Total Rewards Recognition Program
- Supportive and diverse work culture
- Opportunity to work on FDA & EMA submissions
📍 Job Locations
| Role | Location | Type |
|---|---|---|
| Safety Specialist I | Hyderabad | Office-based |
| Safety & PV Specialist II | Hyderabad / Gurugram | Office-based |
📝 How to Apply
Application Link for Safety Specialist I – Hyderabad
Application Link for Safety & PV Specialist II (Literature Review)
Advertisement
