Pharmacovigilance Coordinator (CT/Literature)
🏢 About Syneos Health
Syneos Health® is a global biopharmaceutical solutions organization operating across 110+ countries. The company has supported 94% of novel FDA-approved drugs in recent years and works with global sponsors across clinical development and commercialization.
Syneos Health provides strong exposure to ICH-GCP, GVP modules, global PV regulations, and safety database systems.
📌 Job Overview
Position: Safety & Pharmacovigilance Coordinator (CT / Literature)
Location: Gurugram / Hyderabad
Employment Type: Full-Time (Office-Based)
Experience Required: Minimum 1 Year in PV Case Processing
Preferred Experience: Clinical Trial (CT) & Literature Case Processing
🧾 Key Responsibilities
- Monitor and route incoming safety information to project teams
- Perform accurate ICSR data entry and case processing
- Track safety documentation as per sponsor guidelines
- Redact patient-identifiable data per ICH-GCP & GVP
- Support literature & CT case processing activities
- Assist in translation coordination for safety documents
- Perform query follow-up and submission support
- Maintain case files (electronic & paper)
- Conduct workflow reconciliation activities
- Ensure adherence to SOPs, WIs, and global PV regulations
🎓 Eligibility & Qualifications
- B.Pharm / M.Pharm / PharmD / BDS
- Minimum 1 year PV case processing experience (Mandatory)
- Experience in CT & Literature cases preferred
- Knowledge of safety databases & medical terminology
- Familiarity with ICH Guidelines & GVP Modules
- MS Office proficiency (Word, Excel, PowerPoint, Outlook)
💰 Salary (Estimated)
- ₹3.2 LPA – ₹5.5 LPA (Approximate CTC)
- Final compensation depends on experience & interview performance
🌟 Why Join Syneos Health?
- Global exposure in drug safety & PV operations
- Career progression in Pharmacovigilance
- Training in global regulatory compliance
- Supportive management & structured growth
- Diversity-driven global CRO environment
We use a 15-second timer to encourage careful reading of the job description. Ensure your experience aligns with ICSR Data Entry, Clinical Trial & Literature Case Processing.
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