【Alexion Japan】Director, Head of Alexion Pharma Patient Safety Japan...

Updated: April 20, 2024 02:53 PM GMT

AstraZeneca

Minato City, Tokyo

Position Summary

Director, RDU Patient Safety Japan is responsible for supervising the following tasks as Anseki (安責) and Seichoseki (製調責) to be conducted smoothly and appropriately by each member of the team, related functions and outsourced companies.

1. Collect and maintain safety management information for marketed products in accordance with Japan GVP.

2. Plan and conduct post marketing surveillances and studies in accordance with GPSP.

3. Strengthen the relationship with relevant Patient Safety teams (including AZKK).

4. Coordinate conflicts of interest with other functions in Alexion Pharma Japan (APJ), external companies (vendors) and AZKK.

The position contributes to clarify the safety of the development products by accomplishing the tasks listed below.

Handle SAE information for development products in accordance with GCP. Supporting development related tasks in RDU Japan R&D.

Principal Responsibilities

•Facilitate the operation of RDU Patient Safety Japan with... More Detail