【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.

Date Posted

19-4月-2024

Closing Date

30-12月-2024

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact [email protected]. Alexion participates in E-Verify.

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