【Alexion Japan】Director, Head of Alexion Pharma Patient Safety Japan, AstraZeneca Rare Disease Unit

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 confirming the right resources in AZKK.

•Effectively outsource work to vendor/CRO, improve the efficiency of the work and productivity.

•Obtain the support from AZKK and relevant GPS functions so that the Patient Safety activities of APJ(MAH) are carried out smoothly. Coordinate activities with other functions within APJ to proceed with the work well.

•As Anseki, a registered safety management supervisor required by Japan GVP, oversee and ensure overall safety related tasks for marketed products such as collecting, evaluating safety information and reporting to authorities, including Early Post-marketing Phase Vigilance (EPPV).

•Ensure preparation and revision of package inserts in alignment with Japan RA and execution of safety measures when any of package inserts are revised. Coordinate for preparing and revising other related materials for appropriate use in a timely manner. Create package inserts for a new drug together with other related functions.

•Ensure appropriate handling of serious adverse events (SAE) and distribution of  safety information to sites in accordance with GCP.

•Support R&D activities for development products like JPT, JOT, JST and PADG.

•As Seichoseki, a post marketing study supervisor required by GPSP, ensure the surveillances /studies are conducted appropriately and periodic safety reports and re-examination application are submitted properly.

•Provide safety and efficacy-related information collected by post-marketing surveillance to internal/external parties to contribute to maximizing the value of our medicines.

•Obtain the latest information about the authorities and pharmaceutical industry and apply them to the business. Handle the issues related to the authorities when necessary.

•Make an appropriate budget for RDU Patient safety Japan and maintain and control it.

•Contribute to R&D in APJ as one of J-RDLT members.

Qualifications

•At least 3 years’ experience in PV and 3 year’s experience in PMS or R&D.

•Excellent knowledge of local regulations and requirements for Patient Safety such as GVP, GPSP and GCP.

•Strong knowledge/experience of regulatory inspections with the ability to effectively handle all situations that may occur and determine appropriate strategies and courses of action.

•Solid background and experience in pharmaceutical quality system management (GxP).

•Strong skills of problem solving, decision making, communication and negotiation.

•Experience in people management.

Education

•Bachelor’s degree or higher in pharmacy or other bioscientific fields.

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 authorization and employment eligibility verification requirements.