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Safety & PV Specialist I – Literature Review at Syneos Health | 2+ Years | ₹6–9 LPA
Syneos Health
Gurugram / Hyderabad / Pune
2+ Years
Pharmacovigilance
₹6–9 LPA
📄 Job Overview
Syneos Health is hiring a Safety & Pharmacovigilance Specialist I (Literature Review) for its India operations. This is a full-time office-based role ideal for experienced PV professionals with strong exposure to literature review, ICSR processing, and clinical trial safety.
🧭 Key Responsibilities
- Literature screening and review for PV case identification
- Processing and triaging Individual Case Safety Reports (ICSRs)
- Case management and data entry in safety databases
- MedDRA coding for adverse events and indications
- Drug coding and maintenance of drug dictionaries
- Preparation of high-quality safety narratives
- Duplicate case identification and reconciliation
- xEVMPD product record validation and submission
- SPOR / IDMP compliance activities
- TMF & PSMF safety document submissions
- Support audits, inspections, and regulatory compliance
🎓 Eligibility Criteria
- B.Pharm / M.Pharm / Pharm.D
- MSc / BSc / Life Sciences or equivalent
- Minimum 2+ years experience in PV literature review
- Experience in clinical trial and post-marketing safety preferred
🧠 Required Skills
- Strong knowledge of ICH-GCP, GVP, and global PV regulations
- Hands-on experience with safety databases
- Excellent medical terminology knowledge
- High attention to detail and quality compliance
- Good communication and time-management skills
💼 Why Join Syneos Health?
- Work with a global biopharmaceutical solutions leader
- Exposure to global regulatory safety operations
- Strong learning and career growth opportunities
- Inclusive “Total Self” work culture
📌 Note Before You Apply:
Kindly read the entire job description carefully before applying.
Kindly read the entire job description carefully before applying.
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