Medical Director, Medical Safety (London)

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.

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.

Essential Functions Job Responsibilities and Requirements:

• Lead the preparation and review of safety-related section(s) for 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.
• Support creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI).
• Support review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned product/s.
• Support signal detection activities to ensure signal identification, evaluation, validation, for assigned product including individual and aggregate data analyses.
• 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.
• Contribute to preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks.
• Provide guidance with adverse event (MedDRA) and drug (WHO Drug) coding for clinical and postmarketing safety data.
• Demonstrate or gain knowledge of current and applicable global PV regulations and guidelines.
• Provide safety expertise to due diligence activities, if/as needed.

Required Knowledge, Skills, and Abilities Minimum Requirements:

• Minimum 2-5 years of Clinical Development, Medical Affairs or Drug Safety/Pharmacovigilance experience.
• Excellent knowledge of drug development process.
• Requires a high level of initiative and independence.
• Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork.
• Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word.
• Some national/international travel may be required.

Leadership Skills:

• Enterprise and Proactive Mindset—demonstrate collaborative spirit.
• Set & Achieve Goals: Understand business objectives and effectively translate them into strategies.
• Inspire & Mobilize Others: Serve as a positive role model.
• Understanding of target product profile; clinical designs and/or global PV regulatory environment.
• Exposure to working relationship with the FDA, EMA and other regulatory authorities is preferred.
• Working knowledge of safety databases and electronic data capture systems a plus.
• MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries a plus.
• Ability to manage multiple tasks with deadlines in fast-paced environment.

Required/Preferred Education and Licenses:

• MD required; medical licensure in at least one region preferred.
• Clinical research and/or fellowship training in internal medicine, oncology, neurology, or other relevant specialty is a plus.