■職務内容

The Senior Scientist, PS Strategy (PSS) is accountable for planning the Japan Risk Management Plan (J-RMP) and 
leading the execution of Pharmacovigilance (PV) activities excluding Post Marketing Surveillance (PMS) studies of 
assigned product(s) throughout the entire product’s life cycle. 
• The Senior Scientist, PSS can be assigned as a leader of the Japan Pharmacovigilance Team (J-PVT), a sub-team of 
the Japan Project Team (JPT) and be accountable for the PV strategy of the product(s) in Japan.
• The scope of accountabilities and responsibilities for the Senior Scientist, PSS includes the following key areas:
o To develop and maintain J-RMP, JPI safety part, and relevant documents in a cross-functional team 
incorporating the latest information and in compliance with GVP/GPSP and relevant AZ SOPs. 
o To create the protocol and report of Early Post-marketing Phase Vigilance (EPPV). 
o To implement the optimal safety surveillance of the product in consideration of the safety profile of 
product(s) specifically required for Japanese regulation. 
o To coordinate required data output from the safety database to support communication with external 
stakeholders in Japan. 
o To coordinate transition of required safety data and regulatory mandatory documents associated with 
MAH transfer. 
o To ensure the right quality of PV-related deliverables such as J-RMP, EPPV reports, etc. 
o To escalate any actual/potential compliance issue to relevant operational bodies to support solving it. 
o To have accountability for PV activities of an assigned product in Japan as a representative of J-PVT. 
o To lead and manage J-PVT to enable and drive PV delivery according to the plan including budget and 
timeline. 
o To lead development strategy and options for the PV plan of the product as a J-PVT leader, in 
collaboration with JPT and Safety Strategic Management Team (SSaMT). 
o To lead response to regulatory queries for post-marketing safety matters in collaboration with relevant 
functions including Global Patient Safety. 
o To ensure governance and key stakeholder engagement is effectively managed. 
o To provide leadership as needed in the issue management such as compliance issues, Blue/Yellow letter 
delivery, or product recall for safety issues and in the co-promotion business agreement. 

■応募条件【必須／Mandatory】GVP業務（承認準備～承認後のGVP活動）コミュニケーション能力、社会人としての一般的な素養Business English (月1-2回程度のミーティングと日常的なテキストでのコミュニケーションあり)Fluent in Japanese

【歓迎／Nice to have】グローバルとの実務的な業務コミュニケーション、臨床試験における安全性情報収集や評価、規制当局対応薬剤師、看護師など医療系資格（臨床現場での経験ありの方）薬剤疫学・統計、プロジェクトマネジメント、ファシリテーション、AIリテラシー中国語もしくは韓国語のスキル

【勤務地/Location】Osaka or Tokyo

【キャリアレベル/Career Level】D

Date Posted

20-6月-2025

Closing Date

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