Wat ga je doen?
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 HQ and supports all DSOs and the Affiliate Management Leadership Team (AFM LT) in the execution of their responsibilities. This position is 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 function 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. This position reports to the Affiliate Operations Group Lead.
- Monitor the Global Affiliate Operations inbox and ensure timely responses are generated
- Collect, organize and communicate required information related to (but not limted 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 AFM, the Affiliate Operations Group, DSOs, the EU-QPPV office and/or other 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
Waar ga je werken?
Astellas is a Japanese multinational pharmaceutical company employing over 18,000 people worldwide with global sales exceeding 10 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.
Wie ben je?
- BS/MS degree in life sciences or equivalent;
- An experienced, fully qualified professional with solid understanding of internal policies, processes and procedures;
- Service orientated and pro-active problem-solving attitude; able to provide solutions to a variety of problems that require the regular use of creativity and ingenuity. Ensures solutions are consistent with company objectives and regulatory requirements;
- Ability to work independently / with limited supervision. Self-directed within the scope of the duties and responsibilities;
- Organization and planning skills: ability to establish priorities and co-ordinate tasks;
- Effective written and oral communication skills in English (verbal and written);
- Knowledge of Microsoft office, Excel, Word, PowerPoint;
- Compliance mentality and understanding of good documentation practices.
Wat mag je verwachten?
- A quality orientated organisation in the pharmaceutical industry;
- Working in an international environment;
- Salary based upon experience;
- A temporary contract for 6 months with the possibility to extend.
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