Safety & PV Specialist I - Gurugram / Hyderabad Office based

Overview

Safety & PV Specialist I is an office-based role focused on pharmacovigilance (PV) case processing, quality review, coding, reporting support, and safety tracking activities.

What you'll do

• Enter ICSR receipt and tracking information into PVG quality and tracking systems.
• Process ICSRs per SOPs and project/program safety plans.
• Triages ICSRs and assess ICSR data for completeness, accuracy, and regulatory reportability.
• Enter safety data and code events, medical history, concomitant medications, and tests.
• Compile narrative summaries and resolve information queries.
• Support expedited reporting and maintain safety tracking for assigned activities.
• Perform literature screening/review and support MedDRA coding and drug dictionary maintenance.

What you'll need

• Minimum 2-4 years of ICSR case processing experience.
• Bachelor’s degree in life science, registered nurse, pharmacist, or equivalent education/experience.
• Spontaneous/CT & Literature cases and post marketing CP experience is mandatory.
• Safety database systems knowledge and medical terminology.
• Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, plus ICH GCP and GVP.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint), Visio, Outlook email, and Team Share (or similar).

Details

• Office based in Gurugram / Hyderabad.