セーフティコントロールマネージャー/ Safety Control Manager

A Safety Control Manager position is now available at a global regulatory solutions and services company. The chosen individual will be developing and implementing comprehensive safety control strategies, ensuring the safety and efficacy of pharmaceutical products. This is a temp-to-perm and hybrid role.

Responsibilities:

• Oversee the collection, evaluation, and reporting of adverse events and safety data from clinical trials, post-marketing surveillance, and spontaneous reports
• Prepare and submit safety reports to regulatory authorities in accordance with applicable regulations and guidelines.
• Collaborate with internal departments to ensure alignment of safety control activities with overall business objectives
• Stay informed about changes in regulatory requirements related to drug safety and pharmacovigilance
• Develop and deliver training programs on drug safety principles, pharmacovigilance procedures, and regulatory requirements to internal stakeholders
• Participate in internal and external quality audits to assess the effectiveness of safety control processes

Requirements:

• Bachelor’s degree or above in pharmacy, medicine, life sciences, or a related field (advanced degree: PharmD, MD, PhD is ideal)
• More than 3 years of experience in pharmacovigilance, drug safety, or a related field within the pharmaceutical industry
• Proven leadership abilities with experience managing safety control activities and leading multidisciplinary teams
• In-depth understanding of Japanese regulations and guidelines governing pharmacovigilance and drug safety, including PMDA regulations
• Strong knowledge of international pharmacovigilance regulations (ICH guidelines, EU pharmacovigilance legislation) is a plus
• Excellent interpersonal communication skills
• Fluent level written and verbal Japanese and English

About the Company:

Based overseas, this international company offers end-to-end regulatory and technology services that benefit life science firms.

Keywords:

安全管理, ファーマコビジランス, 薬事コンプライアンス, 遠隔操作, 求人, 外資系, 在宅勤務

2035090/001