Associate Director PV

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募集要項

会社概要

同社は医薬品の研究開発・製造・販売を行っているグローバル企業です。「深刻な病気を持つ患者を助けるための革新的な医薬品を発見／開発し、提供すること」をミッションとし、未来のヘルスケア業界のリーダーとして「フォーカス、イノベーション、コンパッション」を最も大切にしています。重要なアンメット・メディカルニーズのある疾患領域へフォーカスし、革新的な医薬品とサービスの提供を通じて人々を新しい希望へと導き、生活の質の向上に貢献しています。

業務内容

• Responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.

応募条件

• 5 years or more experience to interact with global counterpart(s) in a working environment.
• 5 years or more experience in general safety management division.
• 5 years or more experiences in supervising three or more member team, either as direct repots or multi-layer.
• 5 years or more experience in maintaining safety data management.

Key Competency Requirements:

• Knowledge about Medical Information activities in Japanese industry including the role of Medical Representatives, expected contents and level among HCP.
• Basic knowledge about product-related data scheme including phases and composition of clinical development, characteristics of data from Japanese EPPV and PMS, Architecture of Common Technical Document etc.
• Knowledge about Pharmaceutical and Medical Device Act, Fair Competition Code (FCC), Promotion Code, and any other applicable regulations in Japan.
• Knowledge about Global PV Guideline (ICH-Ex).
• General skills of project management including schedule, budget, quality and issue.
• Communication skills as a professional in Japanese context as well as in global community, both internally and externally.
• Team management skills to lead a team, develop talents, nurture trust and confidence among members, and identify and address issues in a team.
• Evaluate the capability of the CRO under the objective systems, and maximize their ability.
• Advanced level of written English as non-native – can understand medical articles and general business documents in English without dictionary, can develop a document for any kind of job-related topics including complex ones.
• Advanced level as non-native speaker of oral English. Ability to discuss, negotiate and persuade in English within the responsible job-related topics, can represent organization's Pharmacovigilance Japan in a global meeting

給与

1200 - 1600 万円

勤務地

東京