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Senior Medical Director, Medical Safety (MD)
Jazz Pharmaceuticals - Austin, TX
posted about 2 months ago
About the position
The Senior Medical Director/Global Safety Physician at Jazz Pharmaceuticals is responsible for overseeing the global safety strategy and safety profile of the company's products throughout their lifecycle. This role involves leading pre- and post-marketing safety deliverables, managing safety assessments, and ensuring compliance with global pharmacovigilance regulations. The position requires effective cross-functional collaboration and mentorship of junior staff, while also contributing to the preparation of safety-related documents and risk management plans.
Responsibilities
- Provide pharmacovigilance (PV) leadership for clinical development and commercial organization.
- Lead the preparation and review of safety-related sections for clinical and regulatory documents.
- Direct the creation and maintenance of Company Core Safety Information (CCSI).
- Perform review of medical/scientific literature for signal detection activities.
- Lead signal detection activities and communicate safety assessments to stakeholders.
- Contribute to the preparation of pre- and post-marketing aggregate safety reports.
- Lead risk-benefit evaluations and contribute to Risk Management Plans (RMPs).
- Develop and provide training for junior staff in pharmacovigilance processes.
- Ensure compliance with global PV regulations and guidelines.
- Participate in vendor selection activities and contribute to Pharmacovigilance Agreements.
Requirements
- Minimum 2-4 years of Drug Safety/Pharmacovigilance experience, preferably in oncology.
- Excellent understanding of global PV regulatory environment and Good Pharmacovigilance practices.
- Working knowledge of safety databases and electronic data capture systems.
- MedDRA trained with knowledge of MedDRA and WHO Drug coding dictionaries.
- Experience with PV audit processes and regulatory authority inspections.
- Ability to manage multiple tasks and complex projects in a fast-paced environment.
- Excellent written and oral communication skills.
Nice-to-haves
- Clinical research and/or fellowship training in genetics, pediatrics, endocrinology, metabolism, or pharmacology.
Benefits
- Medical, dental, and vision insurance
- 401k retirement savings plan
- Flexible paid vacation
- Discretionary annual cash bonus or incentive compensation
- Discretionary equity grants under the Long Term Equity Incentive Plan
