Affiliate Operations Associate
Astellas Pharma Europe B.V. - Leiden (Nederland)
For our client, Astellas Pharma Europe B.V., we are looking for an Affiliate Operations Associate.
This position serves as the first point of contact between the Drug Safety Officers (DSOs) at the Affiliates, on a Global level, and (Regional) PV Head Quarters and supports all DSOs and the Affiliate Management Leadership Team (AFM LT) in the execution of their responsibilities.
You are responsible for timely collection and exchange of information between (Regional) PV HQ and the DSOs and for supporting resolution of all questions and requests from DSOs.
This position requires a good relationship with the local affiliate DSOs as the performance of the PV affiliates has a direct impact on the Astellas PV system and compliance.
- Monitor the Global Affiliate Operations inbox and ensure timely responses are generated;
- Collect, organize and communicate required information related to the Pharmacovigilance System Master File (PSMF), training records, job descriptions, monthly DSO reports, staff updates, Regulatory Requirements updates, compliance activities and review for accuracy and completeness;
- Conduct mock- and test calls and sends test emails to test DSO 24/7 availability;
- Participate in/support projects related to DSO activities, process improvements or other PV related topics;
- Maintain AFM and DSO sharepoints and ensure all information is up to date;
- Maintain the Global DSO contact and distribution lists;
- Maintain the Job Aid for the Affiliate Operations activities;
- Organize meetings, communication and/or interactions between Astellas (PV) departments;
- Organize DSO introduction meetings (remote and F2F);
- Support the onboarding of new DSOs and/or establishment of a new affiliate;
- Support DSOs and AFM team during PV audits and inspections.
Who we're looking for
For this role, we are looking for a BSc. degree candidate with solid understanding of internal policies, processes and procedures. You are service orientated and have a pro-active problem-solving attitude as well as a compliance mentality and understanding of good documentation practices. As a person, you can work independently and set prioritites with limited supervision. You have strong organization and planning skills and you have effective written and oral communication skills in English (verbal and written).
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||:||Position for at least one 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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