Medical Director, Medical Safety Job at London Full Time

If you are a current Jazz employee please apply via the Internal Career site.

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.

Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit  for more information.

Brief

The Global Safety Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for Jazz Pharmaceuticals product/s (investigational and marketed) throughout their lifecycle. This includes supporting major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation and risk management activities for specific products. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities.

This individual will work together with PV management to ensure the safety assessment of priority product/s, including review of aggregate safety analyses and scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.

Essential Functions

Job Responsibilities and Requirements:

• Lead the preparation and review of safety-related section(s) for product/s. Documents include review of specific clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts/journal articles and other documents as needed, ensuring safety profile reflected for assigned product/s.

• Be a key member, as the safety representative, to a Global Regulatory Team and to a Core Development Team.

• Interface with Risk Evaluation and Mitigation Strategy (REMS) team to optimize risk management of assigned products from a PV perspective.

• Where relevant, support creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling.

• Support review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned product/s, as needed.

• Support signal detection activities to ensure signal identification, evaluation, validation, for assigned product including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with CRSO and PV management.

• Participate in or Lead a Safety Management Team (SMT) for an assigned product.

• Contribute to the preparation and review of pre- and post- marketing aggregate safety reports IND Annual Reports, and 6-monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned product/s.

• Contribute to preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate…