Location: US (East Coast) or Germany
Closing Date: 09 Mar 17
Salary (£): Competitive
Benefits: Bonus / Pension / 42 Days Leave (flexible benefit)
Global Biopharmaceutical Company
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 Medical Director / Global Safety Lead 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 safety case reports based on medical judgment and clinical experience; safety signal detection and evaluation activities; all periodic safety reports, risk management plans and regulatory documents; ensuring definition, implementation and evaluation of risk mitigation activities, and safety input to clinical trial activities as appropriate. It is likely that the GDS Medical Director will have a GDS Product Leader role for one or more development compounds/marketed products.
For the assigned product or products,
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, risk-benefit 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 BRAT, and SMCs 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 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:
Several years of medical experience as a physician
Broad industry experience, preferably including both clinical development and pharmacovigilance experience
(including medical safety evaluation and safety decision-making based on clinical acumen and medical judgment)
Excellent knowledge of product development process and experience of cross-functional team work.
Preferentially prior experience with NDA/BLA or equivalent regulatory submissions or working experience from a Regulatory Agency on reviewing submission files
Firsthand experience in handling safety issues related to known target organ toxicities
Professional experience in an international environment
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
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-6823.
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