- a diverse job at a pharmaceutical company
- an interesting job because of the international contacts
- a temporary contract for 12 months, with the possibility to extent
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 located in Leiden but has tight lines all around the world. The organisation is looking for support for the Pharmacovigilance department Urology & Nephrology. They would like to come in contact with an experienced Associate Medical Safety Director.
As a Medical Safety Director, you are responsible and accountable for the coordination and medical-scientific monitoring and assessment of the safety profile of one or more specific products assigned to the Global TA. In this case you act as a Product Responsible person (PRP). As this position may require more hands on oversight from the Group Lead or (Medical) Director, assigned products may include high priority marketed products, including those which are marketed in multiple regions, and those with multiple license partners; typical, straightforward global development products. You lead GPV Product Responsible Teams for assigned products, co-chairs Global Development Safety Management Teams, and participate in Global Development Core Teams and Global Medical Affairs Core Medical Teams as the pharmacovigilance specialist. Therefore, you ensure the medical safety of products for the assigned Global TA and contributing to an optimal benefit-risk profile. You will also be responsible and accountable for the timely identification and communication of emerging safety issues and safety updates of the Company Core Data Sheet, Investigator’s Brochure and local product labelling. This also includes responsibility for effective and regular communication with the Global TA Group Lead and with the applicable QPPV. Furthermore, you will be responsible and accountable for the design of safety surveillance strategies, management of safety signals for drug products, both in development and marketed products. You will also be responsible and accountable for the risk management of assigned drug products, both in development and marketed products. You will also contribute periodic and ad hoc (e.g. health authority requests) safety reports for assigned products in terms of authoring and review of medical sections, the overall medical-scientific analyses and conclusions.
- at least a master’s degree, preferable MD, DO, PharmD or PhD
- over 6 years of experience in Pharmacovigilance/Medical Safety
- experience in pharmaceutical industry
- experience in project management
- working experience as a PRP
- good communication skills in English
- living in Europe is a preference
Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-043-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.