Global Patient Safety Director
- Interim/Contract
- PVG & Drug Safety, Global Drug Safety
This vacancy has now expired. Please see similar roles below...
Hobson Prior are looking for a Global Patient Safety Director to join a leading science and technology organisation who aim to help and prolong life. You will join them on a contract basis, located in Darmstadt.
Job Responsibilities:
- Recognise and evaluate the risks and thereby contribute to define the safety strategy.
- Deliver timely and accurate medical evaluation of individual and aggregated safety data from pre- and post- authorization sources, i.e. Medical assessment for icsrs, susars.
- Ensure correct meddra coding of adverse events from assigned case reports.
- Prepare psurs/pbrers, medical assessment for other aggregated safety reports (e.g. EU ASR, 6-monthly SUSAR report).
- Ensure provision of a clearly defined safety strategy, in the context of delivering the benefit-risk profile and ensure that plans in place are consistent with delivering this strategy.
- Ensure appropriate oversight of the emerging safety profile of the product, including medical review of individual case safety reports as required, signal detection and evaluation, periodic safety reporting, risk-benefit evaluation and risk management, and that any significant signals or safety issues are escalated appropriately within the company.
- Represent GPS at submission teams and provide safety strategic input into submission relevant documents including the Integrated Safety Summary (ISS) SAP, Integrated Summary of Safety, Clinical Summary of Safety (Module 2.7.4), Clinical Overview (Module 2.5) as well as safety update reports.
- You will coach, support and help develop the other GPS staff in the relevant GPS Product Team; chair the BRAT and smcs as required.
- Represent GPS on cross-functional teams for the product, including e.g. The Global Product Team and any Alert Action Teams, ensuring that all negotiated and agreed deliverables and deadlines for these teams are met (may be delegated as appropriate).
- Ensure delivery of safety aspects to clinical trial activities as appropriate.
Requirements:
- Medical Doctor is essential.
- Previous experience working as a Drug Safety Physician.
Apply now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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CHF30 - CHF40 per annum
Berne, Switzerland
Hobson Prior is currently seeking a Drug Safety Specialist for a contract role with the ability to work remotely from anywhere in Switzerland.
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