募集要項

仕事内容: 楽天メディカル株式会社での募集です。
安全性情報（臨床開発・製販後GVP）のご経験のある方は歓迎です。
Position Summary：
The Associate Director/Director Global Safety Operations will provide leadership and operational oversight for pharmacovigilance and safety operations activities across both pre marketing clinical development programs and post marketing products.
This role supports safety activities in Japan and globally ensuring compliance with applicable regulations company procedures and inspection readiness requirements. The position is responsible for overseeing pharmacovigilance operations post marketing surveillance activities vendor management safety reporting and cross functional collaboration to support the lifecycle management of Rakuten Medical products. The role will contribute to the development harmonization and continuous improvement of global safety processes and procedures while supporting both local and global safety initiatives.

Key Duties and Responsibilities：
・Responsible for all safety related activities deliverables and documentatio…

応募資格

必須: Desired Education Skills and Experience：
・Bachelor’s degree or higher in a life science related field. Healthcare professional qualifications （e.g. Nurse Pharmacist Physician） are preferred.
・7+ years of experience in Pharmacovigilance Drug Safety Clinical Safety or Safety Operations within the pharmaceutical biotechnology or medical device industry. Experience as a Safety Manager or equivalent leadership role is preferred.
・Experience supporting both clinical development and post marketing pharmacovigilance activities.
・Expert knowledge of current pharmacovigilance regulations guidelines and practices including PMDA ICH FDA EMA and other applicable regulatory requirements.
・Experience in developing and maintaining SOPs Risk Management Plans PMS documents …

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会社概要