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メディカル・バイオ - 安全性情報（臨床開発・製販後GVP）
メディカル・バイオ - 製造販売後調査（GPMSP）

The Position manages Pharmacovigilance activities in Japan, ensuring compliance with global and local regulations like GCP, GVP, and GPSP. It supports and may substitute for the Safety Contact Person. Responsibilities include overseeing safety report evaluations, managing Pharmacovigilance Agreements, providing safety information, and maintaining training and audit readiness. The role also involves preparing safety reports, developing Risk Management Plans, and handling GPSP-related tasks. Collaboration with regulatory authorities and internal teams is essential.

■休日：完全週休二日制, 土, 日, 祝日, GW, 年末年始

Professional competencies and business insights
Education:
Bachelor’s or Master’s degree or above / equivalent within science, e.g. pharmaceu-tics, medical or related field is preferable.
Professional experience:
At least 3 years of experience in Pharmacovigilance related activities
Preferable of experience in Post-Marketing Surveillance related activities
Held responsibility in relation to operation of Pharmacovigilance activities including safety profile of Marketed and Investigational products and management of rele-vant staff
Understanding of relevant legislation with regards to Pharmacovigilance under GVP, GCP and GPSP
Possess excellent interpersonal, verbal, and written communication skills. Able to research, compile and provide safety information in a clear concise manner to the local/global team as appropriate.
Possess coaching skills necessary for implementation of human resources develop-ment of subordinates
Management capability of sub ordinates operation including progress management
Experience of GCP, GVP, GPSP inspection by the competent authority


Behavioral competencies
・Integrity and Trust
・Drive for Results
・Innovation Management
・Managing Vision and Purpose
・Business Acumen
・Decision Quality
・Interpersonally Savvy
・Building Effective Teams
・Cross Cultural Agility

■職種未経験者：不可