- a diverse job at a pharmaceutical company
- PRP responsible for post-market products in TA autoimmune
- an interesting job because of the international contacts
- a temporary contract for 12 months with the possibility to extend
As a Medical Safety Manager, you become responsible and accountable for the coordination and medical-scientific monitoring and assessing of the safety profile for assigned products in the Therapeutic Area (TA) autoimmune. You will work with post-market products which may require more hands-on oversight from the Group Lead or Medical Director. Assigned products could be available in multiple regions or have multiple license partners or included a high priority product. You will be responsible for identification and communication of emerging safety issues and updates of core data sheets, investigator`s brochures and local product’s labelling. Furthermore, you will be responsible for the management of safety signals for drug products. You collect and identify safety signals using safety data for signal surveillance activities. Another responsibility is risk management of assigned products. You be responsible for the development, implementation, and submission of risk management plans. Also, you will deliver periodic safety reports for assigned products on time and in high quality for health authorities. In this role you are going to be working in a global team and you report to the Group Leader.
- at least a bachelor’s degree or higher
- minimum of six years’ experience in the pharmaceutical industry
- direct exposure to pharmacovigilance functions, additional regulatory and/or clinical development experience is a plus
- in-depth understanding of safety regulations for marketed products
- specific working knowledge and experience in medical safety functions, including risk, signal management and periodic reports
- excellent communication, presentation and written skills in English
Our client manufactures and markets high-quality drugs in a diversity of fields. The organisation has been undergoing substantial growth and expects to be a global top ten player. In Europe, our client produces, develops, and markets products through a network of affiliated companies. The European R&D and manufacturing activities are concentrated in The Netherlands. The European organisation is in Leiden but has tight lines all around the world. The organisation is looking for support for the Pharmacovigilance department. They would like to meet an experienced Sr. Medical Safety Manager.
Interested? Please send your resume and motivational letter by e-mail, with reference to DT/21-024-DD, to Sandra van Putten: email@example.com. For further information, please call and discuss the opportunity with Sandra van Putten at number +31 (0)33 472 80 87.
Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.