Associate Medical Director, Medical Safety

Essential Functions/Responsibilities

• Implement the global safety strategy and monitor the safety profile of Jazz Pharmaceuticals products.
• Generate all major pre- and post-marketing safety deliverables, including signal, benefit-risk evaluation, and risk management activities.
• Interface cross-functionally at all levels in the organization and with external Regulatory Authorities.
• Work with PV staff to manage the safety assessment of products, including reviewing aggregate safety analyses and scientific literature, preparing safety reports, and communicating changes in the product risk profile to internal and external stakeholders.
• Contribute to the preparation and review of safety-related sections for clinical, regulatory, and scientific documents.
• Collaborate in the creation and maintenance of Company Core Safety Information (CCSI) and ensure its implementation in all Reference Safety Information (RSI).
• Conduct signal detection activities to ensure signal identification, evaluation, validation, and communication of safety assessments.
• Prepare and review pre- and postmarketing aggregate safety reports, including PSURs, PBRERs, PADERs, DSURs, IND Annual Reports, and SUSARs.
• Contribute to the preparation of Risk Management Plans (RMPs) for assigned products.
• Provide guidance with adverse event (MedDRA) and drug (WHODrug) coding for clinical and post-marketing safety data.
• Demonstrate knowledge and ensure compliance with global PV regulations and guidelines, and actively participate in inspection readiness activities, internal audits, and external inspections.
• Maintain knowledge of Jazz Pharmaceuticals indications for investigational and/or marketed products.

Required Knowledge, Skills, and Abilities

• Understanding of global PV regulatory environment and GVP.
• Working knowledge of safety databases and electronic data capture systems.
• MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries.
• Experience with PV audit process and active participation in Regulatory Authority Inspections.
• Knowledge of drug development process.
• High level of initiative and independence.
• Excellent written and oral communication skills, resourcefulness, and personal organization skills.
• Strong cross-functional teamwork skills.
• Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint, and Word.

Required/Preferred Education And Licenses

• MD required (or equivalent); medical licensure in at least one state preferred.
• Clinical research and/or fellowship training in internal medicine or neuroscience, hematology/oncology, or other relevant specialty is a plus.
• Minimum 3 years of Drug Safety/Pharmacovigilance (PV) experience or 3 or more years clinical development experience.

Pay

The full and complete base pay range is: $212,000.00 - $318,000.00. Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy.

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $212,000.00 - $318,000.00. Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: here.