Medical Director, Medical Safety
Not Disclosed•Full-TimeRemote
location_on2041, Ranstead Street, Fitler Square, Center City, Philadelphia, Philadelphia County, Pennsylvania, 19103, United States
About Jazz Pharmaceuticals
Jazz Pharmaceuticals is a global biopharma company dedicated to innovating to transform the lives of patients and their families. We develop life-changing medicines for people with serious diseases, often those with limited or no therapeutic options. Our patient-focused, science-driven approach powers pioneering research and development advancements across a robust pipeline of innovative therapeutics in oncology and neuroscience.
Headquartered in Dublin, Ireland, Jazz operates research and development laboratories, manufacturing facilities, and employs talent in multiple countries committed to serving patients worldwide. Our portfolio includes leading therapies for sleep disorders and epilepsy, alongside a growing range of cancer treatments.
About the Role
The Global Safety Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for Jazz Pharmaceuticals products throughout their lifecycle. This role is critical in supporting major pre- and post-marketing safety deliverables, including signal detection, benefit-risk evaluation, and risk management activities.
In this dynamic position, you will interface cross-functionally at all levels of the organization and with external Regulatory Authorities. Working closely with PV management, you will ensure the safety assessment of priority products by reviewing aggregate safety analyses and scientific literature, preparing safety reports, and communicating changes in the product risk profile to internal and external stakeholders. Success in this role requires the ability to adapt to a changing environment to meet both corporate and patient needs.
Hiring Process
If you are a current Jazz employee, please apply via the Internal Career site. For external candidates, the application process begins by submitting your resume through our careers portal. We review applications to identify candidates who align with our mission and the specific requirements of the role. Selected candidates will be contacted for further steps in the interview process.
Equal Opportunity & Culture
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer. We consider qualified applicants without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. We are committed to fostering a diverse and inclusive environment where all employees can thrive.
Work location
Work model: Remote
2041, Ranstead Street, Fitler Square, Center City, Philadelphia, Philadelphia County, Pennsylvania, 19103, United States
Philadelphia, Pennsylvania
Key Responsibilities
- check_circleInterface with Risk Evaluation and Mitigation Strategy teams to optimize product risk management
- check_circleSupport creation and maintenance of Company Core Safety Information and Reference Safety Information
- check_circleContribute to preparation of pre- and post-marketing aggregate safety reports and regulatory submissions
- check_circleParticipate in or lead Safety Management Teams for assigned products
- check_circleProvide guidance on adverse event and drug coding using MedDRA and WHO Drug dictionaries
- check_circleSupport due diligence activities by providing safety expertise as needed
- check_circleLead preparation and review of safety-related sections for clinical and regulatory documents
- check_circleConduct signal detection activities including identification, evaluation, and validation of safety signals
Requirements
- verifiedMD required
- verified2-5 years of Clinical Development, Medical Affairs or Drug Safety/Pharmacovigilance experience
- verifiedMedical licensure in at least one region preferred
- verifiedClinical research and/or fellowship training in internal medicine, oncology, neurology, or other relevant specialty is a plus
- verifiedProficiency in Microsoft Excel, PowerPoint and Word
- verifiedWorking knowledge of international regulations, GCP, and GVP
- verifiedExposure to working relationship with FDA, EMA and other regulatory authorities is preferred
- verifiedWorking knowledge of safety databases (ARISg, ARGUS, or other safety database applications) a plus
- verifiedMedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries a plus
Nice to Have
Medical licensure in at least one region. Clinical research and/or fellowship training in internal medicine, oncology, neurology, or other relevant specialty. Exposure to working relationship with the FDA, EMA and other regulatory authorities. Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems. MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries.
Benefits & Perks
check_circleMedical, dental, and vision insurancecheck_circle401k retirement savings plancheck_circleFlexible paid vacation
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