CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Astellas Pharma Europe B.V., we are searching for an Affiliate Support Manager.

Keywords

• Pharmacoviliance
• Drug Safety Officer
• Regulatory (regional / global)
• Excellent communication
• Problem solver

Job description
In this role, you are responsible for the day-to-day interactions with the Affiliate Drug Safety Officers (DSO) to ensure all Affiliate local PV systems, processes and procedures are compliant, efficient and in line with global/regional regulatory requirements and Astellas policies and procedures.
You will have frequent interactions with DSOs, Affiliates colleagues, DSO/Affiliate Management, QPPV, PVQA colleagues so excellent communication skills and building good relationships are key.
Responsibilities:

Serve as first point of contact for all DSOs, globally;

Monitor affiliate performance and oversees training of Affiliate staff;

Ensure audit and inspection readiness of Affiliates;

Develop, oversee and implement (associated) CAPAs as the performance of the PV Affiliates has a direct impact on the Astellas PV system and compliance;

Develop and review regional QDs for consistency with regional/global regulatory requirements, SOPs and Astellas' expectations;

Ensure delivery of training to DSOs;

Monitor DSO performance based on predefined KPI;

Initiate and manage process improvement projects related to Affiliate procedures;

Ensure training requirements for DSOs are kept up to date;

Interact with DSO and other staff for implementation of PV-related regional and/or global procedures.

Who we're looking for
The ideal candidate has a BSc. or MSc. degree and at least 5 years of relevant experience. We are looking for a technical expert with an in-depth understanding of all aspects of PV and related disciplines. You have a strong industry mindset and are willing to travel up to 50% (after Covid).
You like to solve complex problems in a creative way and communicates excellent with partners and different departments.
Are you the experienced PV candidate we are looking for?

Company profile
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
Reference: A2100029
Contract: Temporary contract with CLS Services
Education: WO/MSc.
HBO/BSc.
Terms: Salary: >3500
Days of leave: 25 + 13
See here our other employment terms for this vacancy
Contactperson: Aniek Vugts
Phone: +31 (0)88 22 77 555