Associate Director Medical Safety
Website Astellas Pharma Europe B.V.
Do you have a pharmaceutical or a life science background and experience in Medical Safety? Then Astellas has an interesting job opportunity for you.
Associate Director Medical Safety
Your job as an Associate Director Medical Safety
As an Associate Director Medical Safety, you provide medical safety leadership and direction concerning the design and successful implementation of medical safety strategies for one or more specific Astellas products. You ensure cross-functional implementation and follow-up with the appropriate stakeholders. The major features of this job are:
- Design of safety surveillance strategies for assigned Astellas drug products, both those in development and marketed products.
- Authoring and reviewing medical-scientific reports, safety analyses and evaluations.
- Ongoing monitoring and assessment of the safety profile of assigned
- Astellas products.
- Timely identification and communication of emerging safety issues and safety updates.
- Risk management of assigned Astellas products.
- Contribution to periodic and ad hoc safety reports in terms of authoring and review of medical sections, the overall medical-scientific analyses and conclusions.
- Contribution to the improvement of systems, procedures and tools.
Support in inspection/audit preparation.
Your personal qualifications as an Associate Director Medical Safety
- Bachelor or Master Degree in a scientific, health-related field.
- A minimum of 6-8 years of experience in the Pharmaceutical industry, from which 3-4 years of experience in global PV.
- In-depth understanding of safety regulations for both marketed and investigational products and excellent knowledge of regional and global authority requirements.
- Specific working experience in medical safety functions, including experience in analyzing safety data, executing global signal detection activities, global literature review and authoring periodic safety reports and risk management plans.
- Demonstrated ability to work within a global matrix environment.
- Excellent communication and presentation skills in English (both written and spoken).
As an Associate Director Medical Safety, you have strong communication and interpersonal skills coupled with the ability to work across cultures and functions. International travel can be part of the job.
- A challenging job opportunity in an international setting;
- Inspiring and dynamic work climate within a complex matrix-organization;
- Attractive remuneration, which includes: a 13th month
- excellent pension policy
- health insurance compensation
- collective health insurance
- company own saving scheme arrangement
- 25 Holidays + 13 so called ADV Days
- and more….
At Astellas, we believe that nurturing a good relationship with our employees delivers good business results.
It is our stated aim in the VISION for Astellas to be recognised as an Employer of Choice. This means ensuring, we are a highly effective organisation that applies best-in-class people management, creates a positive working environment and has an inspirational company culture. This reflects the working culture of Astellas, outlines our expectations as an employer and captures the essence of our company ethos; CHANGING TOMORROW.
Astellas is a Japanese multinational pharmaceutical company employing over 16,500 people worldwide with global sales exceeding 11 billion euro. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in supply chain, manufacturing and sales & marketing. With over 4,200 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.
Please apply via this link. A VOG and/or background check can be part of the recruitment process.