PV Process Data Assurance Manager
Astellas Pharma Europe B.V. - Leiden (Nederland)
For our client, Astellas Pharma Europe B.V., we are looking for a PV Process Data Assurance Manager.
As process data assurance manager you are responsible for development and maintenance of excellence in Regional Data Assurance, with a focus on operational aspects of individual case safety report (ICSR) and literature global standards and drives quality, consistency and operational efficiency across the Astellas PV Process functions.
- Ensuring the quality of (contracted) work delivered under the PV Process regional function, which directly impacts the effective management of the safety profile of Astellas development compounds and marketed drugs.
- Leads the regional PV process data assurance group ensuring high quality operational data and a variety of QC and training activities associated with ICSR and literature processing.
- Works extensively with vendor personnel and PV process staff within and across the regions to ensure the high data quality required to support the ongoing assurance of the safety profile of Astellas products.
- Supports inspection readiness activities and fulfils the role of a key SME for topics associated with in-house and outsourced operational case safety aspects of PV Process activities for case processing, literature search and assessment.
- Implementation and execution of various PV Process operational support tools to ensure quality and consistency.
- Supports in creating and maintaining global standards for non-medical review and assessment of ICSRs and literature, including case intake, data entry (including the case narrative), unblinding, quality control and monitoring, when performed by the case processing vendor(s).
- Contributes to the successful implementation of annual Data Assurance strategic goals and objectives.
Who we're looking for
For this positions we are looking for an experienced candidate; minimal BSc. and 5 years experience in pharmacoviliance or combined QA/RA/PV.
- Extensive leadership experience, including ability to lead and manage global, multidisciplinary team;
- In-depth understanding of safety regulations for both marketed and investigational products;
- Excellent knowledge of global health authority requirements including ICH, CFR 21, FDAAA, EU GVP module, JP regulations;
- Proven experience with establishing and maintaining (GxP) Qualities Management System;
As a person you are quality minded, have strong interpersonal skills and communication skills.
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people worldwide with global sales exceeding 11 billion euro. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. With over 4,500 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, Anti Infectives, Pain Management and Oncology. The global annual R&D investment of 15% to 20% of sales is evidence of the group’s commitment to improving the health of people worldwide through the provision of innovative and reliable products. Astellas employs around 950 persons in the Netherlands, in Leiden and Meppel.
Additional vacancy information
|Contract||:||Temporary contract with CLS Services|
|Employment terms||:||Project until March 2023. Remote working is possible.|
Salary: max. 52000
See here our other employment terms for this vacancy
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
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