Closing Date: 10 Mar 17
Salary (£): Competitive
Benefits: Car / Bonus / Pension / 30 Days Leave
Global Biopharmaceutical Company
Senior role preferably based in Germany, otherwise can be based US East Coast
Global remit and visibility
English speaker required
The role of the Global Drug Safety (GDS) Senior Medical Director is to ensure effective proactive medical safety strategies for the assigned development compound(s); delivery of safety aspects for clinical development; and risk management and benefit-risk evaluation. This includes delivery of the medical evaluation of single case safety reports based on medical judgment and clinical experience; safety signal detection and evaluation activities; periodic safety reports, risk management plans and regulatory documents; ensuring definition, implementation and evaluation of risk mitigation activities, and delivery of safety aspects of clinical trial activities as appropriate. The GDS Senior Medical Director will have a GDS Product Leader role for a development compound of high medical or strategic importance.
For the assigned product or products, either directly or through effective delegation to other members of the GDS Product Team:
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 based on medical judgment and clinical experience, signal detection and evaluation, periodic safety reporting, benefit-risk evaluation and risk management, and that any significant signals or safety issues are escalated appropriately within the company.
Ensure delivery of safety aspects to clinical trial activities as appropriate.
Coach, support and help develop the other GDS staff in the relevant GDS Product Team; chair the the Benefit-risk Action Team(s) (BRAT), and Safety Monitoring Committees (SMCs) for the respective product(s) as required.
Represent GDS on cross-functional teams for the product, including eg the Global Product Team, Clinical Development Team, Submission 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).
Represent GDS on safety aspects for the product externally, eg engagement with SMCs/IDMCs; preparation of the medical safety aspects for, and attendance at, regulatory authority meetings; interactions with external advisers or opinion leaders; collaboration with colleagues from partnership companies for co-development or co-marketing etc.
Provide product- or TA-specific training to GDS colleagues, and safety training to non-safety colleagues, as required.
Ensure effective communication of product-related aspects in regulatory authority inspections.
QUALIFICATIONS / EXPERIENCE REQUIRED:
Global PV Medical Director / safety lead experience
Phase III to launch safety experience
FDA / EMA experience
For a confidential discussion please telephone Christian Simon at AXESS Limited on 020 8560 2300. To apply, please send your CV to email@example.com quoting reference PW-6821.
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