CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For our client Astellas Pharma Europe B.V. we are searching for a (Senior) Manager Epidemiology.Do you have a PhD in Epidemiology amplified with at least 2 years of (pharmaco)epidemiology and looking for an interesting job? Then we are looking for you!
As (Senior) Manager Epidemiology your responsibilities are:
- Provide specific Pharmacoepidemiology (PE) expertise using appropriate methodologies and tools in researching the natural history of diseases and therapies in order to understand the standards of practice associated with the development of new chemical/molecular entities and/or use of marketed products;
- Provide scientific insights to internal and external cross-functional stake holders (Pharmacovigilance, Clinical, Regulatory, Biostatistics, etc.) to review literature, and design, develop and execute PE studies;
- Contribute to the development and execution of PE project timelines and deliverables;
- Collect, analyse and communicate PE data (such as incidence/prevalence estimates, natural history of disease data) to Pharmacovigilance and Clinical Teams to support analyses and interpretation of safety data gathered from internal and external sources;
- Provide scientific insights in identification and implementation of new technologies and processes for enhancing safety surveillance and risk management;
- Collaborate with Risk Management to develop and manage product specific pre- and post-approval PE components of risk management strategies.
We are looking for a MPH (Master of Public Health) or PhD in Epidemiology, Health Services Research, or related field. You have Epidemiology or Pharmacoepidemiology working experience (2+ years preferred) and demonstrated expertise in utilising pharmacoepidemiology principles, methodologies, and databases for pharmacovigilance projects.
- Knowledge of Clinical Development and Pharmacovigilance business processes;
- Understanding of US and ex-US safety regulations;
- Demonstrated experience in analytical study design and methodologies;
- Ability to work effectively in a matrix setting to resolve issues and achieve common goals;
- Ability to create clarity on projects and teams in ambiguous situations;
- Excellent writing skills;
- Ability to translate scientific literature into PV/regulatory related documents.
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people world-wide. 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, and Oncology. Astellas employs around 950 persons in the Netherlands, in Leiden and Meppel.
Interested? Send us (CLS Services) a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form.