Description
Syneos Health, a top life sciences services organization, is seeking a Senior Safety and Pharmacovigilance (PV) Specialist for a night shift position.
The successful candidate will be responsible for various safety-related tasks, including:
- Processing Individual Case Safety Reports (ICSRs) according to Standard Operating Procedures (SOPs) and project-specific safety plans
- Evaluating ICSR data for completeness, accuracy, and regulatory reportability
- Entering information into PVG quality and tracking systems, safety databases, and coding events, medical history, concomitant medications, and tests
- Compiling narrative summaries and identifying information to be queried
- Assisting in generating timely and accurate reports in accordance with regulatory requirements
- Performing literature screening and review for safety, drug coding, and MedDRA coding
- Validating and submitting xEVMPD product records and managing duplicate ICSRs
The ideal candidate will have:
- A minimum of 6 years of PV experience
- ICSR case processing experience along with Quality Check (QC) experience
- A degree in B. Pharm / M. Pharm / BDS / BMS / MBBS
Syneos Health offers a dynamic work environment with opportunities for growth and development.
The position is based in Gurugram, Hyderabad, or Pune office.