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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
Qualifications
Education
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 accommodations@Alexion.com. Alexion participates in E-Verify.
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