Aggregate Safety Assessment Manager
For our client, Astellas Pharma Europe B.V., we are looking for an Aggregate Safety Assessment Manager.
As an Aggregate Safety Assessment (ASA) Manager you will be responsible for contributing to and overseeing the periodic aggregate safety reporting activities in Global Pharmacovigilance (GPV) to enhance quality of pharmacovigilance activities. Additionally, you will ensure excellence in periodic aggregate safety reports mandated by worldwide regulatory authorities. You will work together with people in the US, Japan and Leiden.
You will also contribute to the best practice of periodic aggregate safety reporting activities, as well as ad hoc reporting to ensure the safety of company products. Training of GPV staff on global regulatory requirements and guidelines for periodic reporting is also your responsibility. Furthermore, you will maintain close alliances with relevant functions, both internal (GPV) and external (RA, GMA, Clinical Development) partners to ensure high-quality periodic reporting activities. You strictly comply with all relevant authorities and regulations. Moreover, you contribute to the execution and oversight of the worldwide ASA activities: both in-house and possible out-sourced ASA activities. In this role you report to the Director ASA and contribute to the implementation and successful execution of the GPV mission, objectives and 3-5 year strategic plan.
Who we're looking for
We are looking for a candidate with a postgraduate Science or Medical degree (PhD., Pharm.D, MD). You have at least 5 years of experience in the health science-related industry with direct exposure to clinical, regulatory or pharmacovigilance functions, including:
Skills and competencies:
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||:||Salary: >45000|
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|
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.