An international biopharmaceutical company headquartered in Dublin, Leinster, Ireland, Jazz Pharmaceuticals has U.S. offices in Palo Alto, California; Philadelphia, Pennsylvania; a
Medical Director, Medical Safety
Location
Worldwide
Posted
76 days ago
Salary
$256K - $384K / year
Seniority
Lead
No structured requirement data.
Job Description
Medical Director, Medical Safety
Jazz Pharmaceuticals
Role Description 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. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential. Essential Functions - Lead the preparation and review of safety-related section(s) for product/s, including clinical, regulatory, and scientific documents. - 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. - Support creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation in all Reference Safety Information (RSI). - Support review of medical/scientific literature for signal detection activities and aggregate reporting. - Support signal detection activities to ensure signal identification, evaluation, validation, and documentation of safety assessments. - 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. - 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 needed. - Keep abreast of new PV/safety regulations and guidance from regulatory authorities. Qualifications - Minimum 2-5 years of Clinical Development, Medical Affairs or Drug Safety/Pharmacovigilance experience. - Excellent knowledge of drug development process. - High level of initiative and independence. - Excellent written and oral communication skills. - Resourcefulness and personal organization skills. - 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. - 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 is a plus. - MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries is a plus. - Ability to manage multiple tasks with deadlines in a 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. Benefits - Medical, dental, and vision insurance. - 401k retirement savings plan. - Flexible paid vacation. - Discretionary annual cash bonus or incentive compensation. - Discretionary equity grants in accordance with Jazz’s Long Term Equity Incentive Plan.
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