■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】

経験

　・海外と協働した活動（理想はグローバルロール）を経験している

　・社会人としての最低限の素養

　・医薬品開発プロセスにかかる知識と経験

能力

　・新しい挑戦に向け、ソフト・ハード面で自ら推進できる能力を持つ方

　・新しいことに積極的に挑戦することを厭わず、１つのことから多くを吸収できる姿勢を持っている

語学

　・Japanese：Native

　・English：Business English (verbal and non-verbal)

【歓迎／Nice to have】

経験

　・業務範囲と一致するTAエリアの臨床的・薬理学的知識

　・PVにかかる科学的な活動

資格

　・Qualified degree in Pharmacy/ Medical/ Science

能力

　・新しい挑戦のリスクを把握しながらアイデアを調整、提案できる能力がある

【勤務地/Location】Osaka or Tokyo

【キャリアレベル/Career Level】D