■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

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.