Pharmacovigilance Quality & Compliance Manager

Job title: Pharmacovigilance Quality & Compliance Manager

• •Location: Tokyo
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• Job role
• •Fulfill responsibility that processes to comply with local PV regulations and the global procedures are implemented, documented and followed locally (QD management, self-inspection, etc.)
• •Fulfill responsibility on creation and revision of SDEA, PV contract for safety information exchange and/or GVP and non-GVP agreement. Serves as a consultant/advisor GPV contracts serving Japan PV business.
• •Fulfil responsibility on storage including document transfer at a transfer of approval. Window person of document management in Japan PV.
• •Take control Audit and Inspection and its preparation. Coordination of GVP inspection and GxP Audit. Hard knowledge and experience about Audit/Inspection.
• •Fulfill responsibility to lead Quality in J-PSPV by conducting “self-inspection”, “Change Management, and “Deviation Management /CAPA implementation” . Understand the Global Quality process and implement it to Japan considering local regulation.
• •Within Japan organization, to be a window person of training about general topic and local regulation for safety mutters. Keep communication to global training leader and implement to Japan. Leader of Japan GVP training program.

Personal requirements

• •Ability to create and implement appropriate safety processes from quality and compliance standpoint.
• •High level of coordination, communication and negotiation skills.
• •Solid knowledge of audit/inspection, experience with Japan GVP.
• •Commitment and ethical standard to fulfill responsibility in keeping SaKK in compliance with both global and local PV regulatory obligations

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