Safety & PV Specialist I - Literature review

Overview

Safety & PV Specialist I focusing on literature review and pharmacovigilance-related activities, including literature screening, safety data entry, coding, and quality review.

What you'll do

• Enter ICSR receipt and tracking information into PVG quality and tracking systems.
• Assist in processing ICSRs per SOPs and project/program safety plans.
• Triages ICSRs and evaluates data for completeness, accuracy, and regulatory report ability.
• Perform literature screening and review for safety, including MedDRA coding and drug dictionary maintenance.
• Compile narrative summaries and resolve queries by identifying information needed and following up.
• Maintain safety tracking for assigned activities and support expedited safety reporting.

What you'll need

• Bachelor’s degree in life science, registered nurse, pharmacist, or an equivalent education/experience combination.
• Safety database systems knowledge and medical terminology understanding.
• Good understanding of clinical trial process across Phases II–IV and/or post-marketing safety requirements.
• Knowledge of ICH GCP and GVP and safety/pharmacovigilance regulations.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint), Visio, Outlook email, Team Share (or similar), and internet.
• Excellent written and spoken communication and interpersonal skills.

Details

• Location: Gurugram, India.