Safety & PV Specialist I - Literature Case processing

Overview

Safety & PV Specialist I responsible for literature case processing, including ICSR triage, coding, database entry, and safety reporting tasks.

What you'll do

• Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs.
• Assist with processing of ICSRs per SOPs and project/program-specific safety plans.
• Triages ICSRs and evaluates ICSR data for completeness, accuracy, and regulatory reportability.
• Enter data into the safety database and compile narrative summaries.
• Perform literature screening/review for safety and required coding using MedDRA and drug dictionaries.
• Maintain safety tracking for assigned activities and support timely expedited reporting.

What you'll need

• 2+ years of experience in literature data entry with MLM experience.
• M.Pharma / BDS / Pharm D degree or equivalent.
• Knowledge of safety database systems and medical terminology.
• Understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint), Visio, Outlook email, and Team Share (or similar).
• Excellent written and spoken communication and interpersonal skills.

Details

• Location: Gurugram, India.