About the Role
Responsibilities:
Handling and assist management of safety related information of investigational products in accordance with GCP and support development tasks.
Handling and assist management of safety related information of marketed products in accordance with GVP
Planning and implementation of measures for securing safety such as information providing/disseminating, and assist management of those tasks
Implement and assist management of other GVP/GCP activities (archiving, SOP management, Training, Outsourcing, etc.)
Managing GVP/GPSP SOPs/WIs/other documents in Japan
Managing Vender including sign GVP agreement and PVA
Managing Organized Data Collection System (ODCS)
Main Responsibilities and Accountabilities
1. Implement and assist management of collecting and evaluating safety management information such as AEs or infection cases and reporting to a...
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