メディカル・バイオ - 安全性情報（臨床開発・製販後GVP）

The PV Risk Manager provides strategic and operational leadership for pharmacovigilance in Japan, ensuring compliance with global and local regulations. Key responsibilities include safety surveillance for MAH and development products, preparation of J-RMP, PSUR, DSUR, and CTD safety modules, implementation of risk minimization measures (e.g., EPPV), and acting as the local PV representative in clinical studies. The role also involves managing PV vendors, maintaining safety systems and SOPs, responding to regulatory inquiries, supporting inspections and audits, and delivering PV training. Strong collaboration with global and local stakeholders is essential.

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

◆Education/Learning Experience/Work Experience
•University level qualification in biosciences, healthcare, or pharmacy.
•At least 3-year experience post-graduation in the pharmaceutical industry, preferably Patient
Safety and/or Clinical/Drug Development, or regulatory agency.
•At least 3-year previous experience of pharmacovigilance, including advanced/solid knowledge of local PV regulations.
•Appropriate experience with local regulatory agency interaction.

◆Skills/Knowledge/Languages
•Expert knowledge of pharmacovigilance related regulatory requirements, and local pharmacovigilance legislation and guidelines (e.g. GCP,GVP).
•Analytical skills.
•Ability to work proactively, independently and collaboratively.
•Fluent in written and oral English

■職種未経験者：不可