Medical Director, Medical Safety (Cambridge)

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.
• 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.
• Set & Achieve Goals.
• Inspire & Mobilize Others.
• 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.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.