Pharmacovigilance Quality & Compliance Manager
Core
Ensure compliance with local PV regulations and global procedures for Japan PV business, including QD management, self-inspection, and document control.
Role type
Pharmacovigilance Quality & Compliance Manager
Builds
Local implementation of global quality processes, PV contracts, and training programs for Japan.
Domain
Pharmaceuticals / Pharmacovigilance / Regulatory Compliance
Required skills
Knowledge of Japan GVP, Audit/Inspection experience, Change Management, Deviation Management, CAPA implementation, Document management, Training leadership
Preferred skills
High level coordination, communication, negotiation skills, Ethical standards
Technologies
GVP, QD management, SDEA, GxP
Responsibilities
Create and revise PV contracts (SDEA, GVP/non-GVP), Lead self-inspection and Change/Deviation Management, Coordinate GVP inspections and GxP audits, Manage document storage and transfer, Lead local training on safety matters and regulations.
Seniority
Manager, hands-on IC