非公開
Safety Process Group is responsible for:
・Deliver training to the members who are responsible for collecting safety information (e.g. sales reps, CRAs, CROs)
・ Support creation of safety information exchange/collection process with relevant parties to facilitate comprehensive and speedy safety data exchange/collection (e.g. global interface organization, safety science, licensees/licensors, clinical study team, medical affairs)
・Support to create and implement case handling process that addresses to the product specific local RMPs if needed
・Ensure safety information (Marketed drug: ICSR; Investigational medicinal product: ICSR, research report, measures taken report, annual report) is submitted without delay to the relevant parties (Regulatory authority, License partners, Clinical Operation, Collaboration partners)
・Accommodate changes of the regulatory requirements and critical business needs
・ Lead planning and execution of training activities with an appropriate network such as functional training coordinators, or other department members
・Lead activities to establish and maintain the framework to ensure an appropriate document recording and archiving
・Self-inspection responsible person: To enhance quality management in both GVP/GPSP control unit and operation unit through self-inspection activities to secure pharmacovigilance activities in compliance with the appropriate standards such as GVP/GPSP
・Contract responsible person: To secure appropriate documentation of safety agreements (mainly GVP/GPSP contract)
・Identify any potential risks/opportunities along with possible contingencies to ensure the appropriate PV activity in order to ensure relevant compliance
・Collaborate with relevant functions across Global and Japan organizations
ワークライフバランスの良さや、社内(国内外)での豊富なキャリアパスが用意されている点が特徴のグローバル企業です。