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 in managing the safety assessment of products, 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.
• 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 implementation of CCSI 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.
• Represent PV in cross-functional forums and committees involving products under responsibility to achieve the Company’s goals.
• Maintain knowledge of Jazz Pharmaceuticals indications for investigational and/or marketed products.

Required Knowledge, Skills, and Abilities

• Understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards, 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 with active participation in Regulatory Authority Inspections.
• Excellent written and oral communication skills, resourcefulness, and personal organization skills.
• Knowledge of drug development process.
• High level of initiative and independence.

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

Full and complete base pay range: $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.

Benefits

Jazz Pharmaceuticals offers a comprehensive benefits package including medical, dental, and vision insurance, 401(k) retirement savings plan, and flexible paid vacation. For more information on our benefits offerings, please click here.