For our client Astellas, based in Leiden, We are looking for a Senior Medical Safety Manager. In this role, you will are responsible for supporting the design and successful implementation of medical safety strategies for drug products within the Global TA. you do this by authoring and reviewing medical-scientific reports, safety analyses and evaluations and ensuring cross-functional implementation and follow-up with the appropriate stake holders. You will support the development, and implementation of process improvements tools, systems and procedures to ensure efficiency and consistency in safety surveillance.
Additionally, you will support in inspection/audit preparation, timely execution and submission of responses to findings and for timely planning, creation, submission, implementation, maintenance and follow-up of corrective and preventive action plans. Finally, you are accountable as a product responsible person (PRP) for pro-active safety surveillance for both products in development and marketed products. This includes leading PV Product Responsible Teams as a PV specialist, ensuring the medical safety for the assigned compounds or products, contributing to an optimal benefit/risk profile, and responsible for the design and successful implementation of signal management and risk management strategies.
Over de werkgever
Astellas Pharma Europe is a Japanese multinational pharmaceutical company employing over 17,000 people worldwide with global sales exceeding 10 billion euro. We are now hiring for the office based in Leiden.
Wat wij bieden
- A temporary contract for at least 1 year;
- 25 holidays (based on fulltime);
- working from home;
- 8,33% Holiday pay;
- opportunities to follow courses and training.
Are you able to handle conflict situations, think strategically, generate solutions to problems, build consensus, and understand differences in both regulations and cultures? Then we are looking for you!
Who we're looking for:
- You have a Ph.D. or M.D. with at least 4 years of experience in a pharmacovigilance position in pharmaceutical industry;
- You have knowledge of safety regulations for both marketed and investigational products, and general knowledge of regional and global authority requirements, including ICH;
- You have specific working knowledge and experience in medical safety functions, including risk, signal management and periodic reports;
- You are able to influence decisions relating to patient safety and assessment of benefit-risk;
- Someone with sound medical scientific knowledge to evaluate and interpret clinical and scientific data and to communicate with both internal and external stake holders.
Wat wij bieden