Syneos Health®, a global leader in biopharmaceutical solutions, has announced new Pharmacovigilance job openings in India for Safety & PV Specialist I and Safety & PV Specialist II roles. These full-time, office-based opportunities are available in Gurugram, Hyderabad, and Pune, offering strong career growth in clinical trial safety and literature case processing.
With a proven track record of supporting 94% of novel FDA-approved drugs and 95% of EMA-authorized products, Syneos Health provides an excellent platform for professionals seeking long-term careers in drug safety, PV operations, and regulatory compliance.
Open Positions at Syneos Health
1. Safety & PV Specialist I
- Experience Required: Minimum 2 years
- Focus Area: Clinical Trial (CT) or Literature Case Processing
2. Safety & PV Specialist II (Literature / CT Processing)
- Experience Required: Minimum 3.5 years
- Focus Area: Advanced ICSR processing, quality review, and regulatory submissions
Key Responsibilities (Both Roles)
- Process and triage Individual Case Safety Reports (ICSRs) as per SOPs and safety plans
- Perform case data entry, MedDRA coding, and narrative writing
- Conduct literature screening and safety review
- Identify, manage, and reconcile duplicate ICSRs
- Perform quality review of safety cases
- Support xEVMPD submissions, SPOR/IDMP activities
- Maintain safety tracking and ensure regulatory compliance (ICH GCP, GVP)
- Submit relevant documents to TMF and PSMF
- Participate in audits and inspections
- Collaborate with cross-functional global PV teams
Qualifications & Skills Required
- Education: B.Pharm / M.Pharm / Pharm.D / BDS
- Experience:
- Specialist I – 2+ years
- Specialist II – 3.5+ years (mandatory CT or literature case processing)
- Strong knowledge of pharmacovigilance regulations, ICH, GVP
- Hands-on experience with safety databases and medical terminology
- Understanding of clinical trial phases II–IV and post-marketing safety
- Proficiency in MS Word, Excel, PowerPoint, Outlook
- Excellent communication, documentation, and organizational skills
Why Join Syneos Health?
- Work with a company supporting 675,000+ clinical trial patients globally
- Strong career development and internal mobility programs
- Inclusive Total Self culture promoting diversity and well-being
- Exposure to global PV projects, audits, and regulatory submissions
- Competitive compensation and rewards
Job Locations
- Gurugram, Haryana
- Hyderabad, Telangana
- Pune, Maharashtra
Estimated Salary (India)
- Safety & PV Specialist I: ₹6,00,000 – ₹9,00,000 per annum
- Safety & PV Specialist II: ₹9,00,000 – ₹14,00,000 per annum
(Salary may vary based on experience, location, and project requirements)
How to Apply
Application Link for Safety & PV Specialist I (Gurugram/Hyderabad / Pune)
Application Link for Safety & PV Specialist II (Literature or Clinical Trial Case Processing)
