Senior Medical Safety Manager
Astellas Pharma Europe B.V. - Leiden (Nederland)
For our client, Astellas Pharma Europe B.V., we are looking for a Senior Medical Safety Manager .
As Senior Medical Safety Manager, you are responsible for supporting the design and successful implementation of medical safety strategies for drug products within the Global TA. you do this by authoring and reviewing medical-scientific reports, safety analyses and evaluations and ensuring cross-functional implementation and follow-up with the appropriate stake holders. You will support the development, and implementation of process improvements tools, systems and procedures to ensure efficiency and consistency in safety surveillance. Additionally, you will support in inspection/audit preparation, timely execution and submission of responses to findings and for timely planning, creation, submission, implementation, maintenance and follow-up of corrective and preventive action plans.
Finally, you are accountable as a product responsible person (PRP) for pro-active safety surveillance for both products in development and marketed products. This includes leading PV Product Responsible Teams as a PV specialist, ensuring the medical safety for the assigned compounds or products, contributing to an optimal benefit/risk profile, and responsible for the design and successful implementation of signal management and risk management strategies.
Who we're looking for
The ideal candidate has a Ph.D. or M.D. with at least 4 years of experience in a pharmacovigilance position in pharmaceutical industry. Additional regulatory and/or clinical development experience is a plus. You have in-depth understanding of safety regulations for both marketed and investigational products, and general knowledge of regional and global authority requirements, including ICH, and other applicable requirements. You have specific working knowledge and experience in medical safety functions, including risk, signal management and periodic reports You are able to influence decisions relating to patient safety and assessment of benefit-risk. You have demonstrated leadership responsibilities, including the ability to work within a matrix environment. We are looking for someone with sound medical scientific knowledge to evaluate and interpret clinical and scientific data and to communicate with both internal and external stake holders. Excellent communication skills (English) and interpersonal skills are, therefore, a must!
Are you able to handle conflict situations, think strategically, generate solutions to problems, build consensus, and understand differences in both regulations and cultures? Then we are looking for you!
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people world-wide 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 world-wide 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 for at least 1 year|
Days of leave: 25 + 13
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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