Advertisement
Syneos Health, a global leader in biopharmaceutical solutions, is hiring a Safety & Pharmacovigilance (PV) Specialist I for a full-time remote role in India. This opportunity is ideal for life science professionals seeking to build or advance a career in pharmacovigilance, drug safety, ICSR processing, and regulatory compliance within a globally recognized CRO.
With operations spanning 110+ countries and involvement in 94% of FDA-approved novel drugs, Syneos Health offers a strong platform for long-term growth in clinical safety and PV operations.
Key Job Responsibilities – Safety & PV Specialist I
As a Safety & PV Specialist I, you will support end-to-end pharmacovigilance activities across clinical and post-marketing programs:
Advertisement
- Processing and tracking Individual Case Safety Reports (ICSRs) in PV databases
- Data entry, validation, and quality review of safety cases
- Triage and assessment of ICSRs for completeness, accuracy, and regulatory reportability
- MedDRA coding for adverse events, medical history, and indications
- Coding of concomitant medications and laboratory tests
- Preparation of high-quality narrative summaries
- Identification, follow-up, and resolution of safety queries
- Support expedited regulatory reporting as per global timelines
- Duplicate case identification and management
- Literature screening and review for safety signals
- Maintenance of drug dictionaries and safety tracking logs
- xEVMPD validation and submission, including MedDRA indication coding
- Activities related to SPOR / IDMP compliance
- TMF and PSMF document submission per SOPs
- Participation in audits and inspections
- Ensuring compliance with ICH-GCP, GVP, global PV regulations, and Syneos SOPs
Required Qualifications & Skills
Educational Qualification
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or equivalent experience
Experience & Knowledge
- Knowledge of pharmacovigilance and drug safety processes
- Understanding of clinical trial phases II–IV and post-marketing safety
- Familiarity with ICH GCP, GVP, and global safety regulations
- Hands-on exposure to safety databases and medical terminology
Technical & Soft Skills
- Proficiency in MS Word, Excel, PowerPoint, Outlook
- Strong attention to detail and data accuracy
- Ability to manage multiple priorities and meet deadlines
- Excellent written and verbal communication skills
- Ability to work independently and within cross-functional teams
Why Join Syneos Health?
- Remote work flexibility (India-based)
- Global exposure to innovative clinical and post-marketing programs
- Strong focus on career development and technical training
- Inclusive Total Self culture promoting diversity and well-being
- Competitive compensation and total rewards program
- Opportunity to work on FDA and EMA-approved products
Salary & Compensation (Estimated)
- ₹5,00,000 – ₹8,00,000 per annum (CTC)
(Salary may vary based on experience, skills, and internal benchmarks)
How to Apply – Safety & PV Specialist I
Advertisement
