Safety & PV Specialist I -Japanese Language expert

Overview

Safety & PV Specialist I (Japanese Language expert) supporting pharmacovigilance processes, including ICSR handling, coding, reporting support, and safety database/tracking activities.

What you'll do

• Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs.
• Assist in processing ICSRs per SOPs and project/program safety plans.
• Triages ICSRs and evaluate ICSR data for completeness, accuracy, and regulatory reporting suitability.
• Enter data into safety databases and code events, medical history, concomitant medications, and tests.
• Compile narrative summaries and follow up to resolve information queries.
• Support timely, consistent, and accurate expedited reporting per regulatory requirements.
• Perform literature screening/review for safety and conduct MedDRA coding and drug dictionary maintenance as required.

What you'll need

• Bachelor’s degree in life science, registered nurse, pharmacist, or equivalent education/experience.
• At least JLPT N3 certification.
• Knowledge of medical terminology.
• Good understanding of clinical trial process across Phases II–IV and/or post-marketing safety requirements, including ICH GCP and GVP.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, Outlook, and Team Share (or similar tools).
• Excellent written and spoken communication and interpersonal skills.

Details

• Location: IND-Gurugram.