For our client in Leiden, Astellas Pharma Europe, we are looking for a PV Process Governance Manager. As a PV Process Governance Manager you will be responsible for defining standards for PV process related matters and procedures in line with the global PV process strategy. You will be involved in the development and maintenance of global standards and processes for case processing and related activities.
- Defining standards for AE intake requirements;
- You will continuously assess processes and identify opportunities to improve efficiency, effectiveness and compliance;
- You will lead projects up to the implementation of process improvements;
- You will manage planned and unplanned deviations and ensure accurate periodic review;
- Liaison with PV functional teams (Medical Safety Science) for impact of process changes.
- You assist with setting standards, decision making and maintenance of product specific case handling conventions in consultation with the PV Process Manager.
Over de werkgever
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.
Wat wij bieden
- We offer a fulltime position at an international dynamic environment ;
- During Covid-19 you will be working from home;
- Salary is based on knowledge and experience (between €4774,- - 6820,-);
- A contract until 31-03-2022 with the possibility to extend.
- at least an MSc in Life-/Health Sciences;
- at least 7 years relevant experience;
- excellent oral and written communication skills in English;
- able to lead complex process improvement projects and able to make decisions;
- Six Sigma or similar process improvement methodology knowledge is a plus.
Voor deze functie is er geen minimale werkervaring vereist
Wat wij bieden