【AstraZeneca】【R＆D】Senior Scientist, 研究開発本部 ペイシェントセーフティ統括部 ペイシェントセーフティ ストラテジーオンコロジー部

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.

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.

Mandatory】

Nice to have】

Location】Osaka or Tokyo

Career Level】D

Date Posted

20-6月-2025

Closing Date