Associate Medical Safety Director
Astellas Pharma Europe B.V. - Leiden (Nederland)
For our client, Astellas Pharma Europe B.V., we are looking for an Associate Medical Safety Director .
As Associate Director Medical Safety, you are responsible for providing medical safety leadership and direction to Global TA colleagues and support to the Global TA Group Lead with regards to the design and successful implementation of medical safety strategies for marketed drug products in the Transplantation field, by authoring, reviewing and, as appropriate, approving medical-scientific reports, safety analyses and evaluations and ensuring cross-functional implementation and follow-up with the appropriate stake holders in and outside Medical Safety (MS) and the PV organisation.
You are responsible and accountable for the risk management of the drug product, the development and submission of the Risk Management Plan (RMP) and for the execution of risk management strategies in collaboration with internal and external stake holders, working closely with Safety Science.
- Responsible and accountable for timely and high-quality contribution to periodic and ad hoc (e.g. Health authority requests) safety reports for assigned products in terms of authoring and review of medical sections, the overall medical-scientific analyses and conclusions;
- Responsible and accountable for the ongoing monitoring and assessment of the safety profile of the product as a member of study teams and for representing PV in the design, conduct, analysis and reporting.
Who we're looking for
The ideal candidate has an M.Sc. or Ph.D. with at least 6 years of Pharmacovigilance experience, preferably within a medical safety position. Experience in the field of Transplantation is highly advantageous.
You have in-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of regional and global authority requirements, including ICH. You are able to influence decisions relating to patient safety and assessment of benefit-risk. As this is a complex product, you should be able to analyse and summarise data from large data sets, and translate the data into documents like aggregate and periodic safety reports.
Do you have the right experience, excellent scientific writing skills and are you proficient in Excel? 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||:||Salary: >5000|
Days of leave: 25 + 13
See here our other employment terms for this vacancy
Project for at least 1 year.
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
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