Looking to advance your career in pharmacovigilance (PV)? Syneos Health is hiring for the role of Safety & PV Specialist I (Immediate Joiner) across Pune, Gurugram, and Hyderabad. This is an excellent opportunity for professionals with 4–4.5 years of experience in literature case processing and expertise in Argus or PV databases.
If you have hands-on experience in ICSR processing, literature screening, and safety data review, this role offers a strong platform to grow in global drug safety operations.
Job Overview
- Role: Safety & PV Specialist I
- Company: Syneos Health
- Locations: Pune, Gurugram, Hyderabad (Hybrid)
- Experience: 1–4 years (Preferred: 4–4.5 years)
- Openings: 10
- Employment Type: Full-time, Permanent
- Industry: Pharmaceutical & Life Sciences
Key Responsibilities
- Perform literature case processing and review in pharmacovigilance workflows
- Identify and extract adverse events from scientific literature
- Conduct duplicate checks and case triage for literature ICSRs
- Enter and manage safety data in Argus / ARISg / LSMV databases
- Ensure compliance with ICH-GCP, PV guidelines, and regulatory requirements
- Maintain accuracy in medical coding and terminology (MedDRA)
- Collaborate with cross-functional teams for case processing and submissions
Required Qualifications
- Educational Qualification:
- B.Pharm, M.Pharm, MBBS, BDS, MDS or equivalent
- Experience:
- 4–4.5 years of literature case processing in pharmacovigilance
- Strong knowledge of ICSR workflow and safety reporting
- Technical Skills:
- Hands-on experience with Argus Safety Database / ARISg / LifeSphere MultiVigilance (LSMV)
- Understanding of medical terminology and MedDRA coding
- Soft Skills:
- Strong communication and analytical skills
- Attention to detail and regulatory compliance mindset
Preferred Skills
- Experience in global literature screening (EMA, PubMed, etc.)
- Knowledge of CIOMS forms, MedWatch, and XML submissions
- Familiarity with PV compliance metrics and quality checks
Benefits of Joining Syneos Health
- Opportunity to work with a global CRO leader in pharmacovigilance
- Exposure to end-to-end safety case processing and regulatory submissions
- Hybrid work flexibility across major pharma hubs
- Career growth in drug safety, risk management, and aggregate reporting
How to Apply
