Tech Stack

Description

You will handle case processing activities including intake, triage, data entry, and quality review of adverse event reports from various sources. You will also conduct follow-up queries and ensure regulatory compliance in a remote, contract role supporting pharmacovigilance operations.

Requirements

• Bachelor's or Master's in Pharmacy or Life Sciences
• 3-5 years of relevant experience in pharmacovigilance
• Hands-on experience with MS Office applications
• Must be able to write and speak Japanese
• Training and mentoring skills for ICSR and safety database

Responsibilities

• Perform intake/triage, data entry, quality review, case finalization/distribution
• Raise follow-up queries with documentation in safety database
• Use ARGUS database for case processing
• Handle rare disease portfolio cases
• Ensure knowledge of ICH-GCP, GVP modules, 21 CFR guidelines