The Medical Safety Physician will be responsible for medical review of individual case safety reports, performing aggregate safety data review and safety surveillance activities for potential safety signals, and review and assurance of medical/pharmacovigilance content and clinical relevance of regulatory safety documents, including those as part of regulatory submissions for new licence/marketing authorisation applications.
- Provide medical review of individual case safety reports (clinical and spontaneous), including coding, seriousness, expectedness and Company causality assessment for an assigned product or therapeutic area
- Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment
- Perform aggregate safety data review, safety surveillance activities to review for potential safety signals, and provide guidance on the regulatory status for expedited reporting and/or signal detection/trends
- Work with clinical counterparts as needed, including review clinical study protocols, development plans and serious adverse event handling
- Communicate and interact effectively within and across therapeutic teams, and within functional team management as appropriate
- Provide pharmacovigilance support for internal and external customers
- Provide medical and scientific expertise on pharmacovigilance matters affecting the preparation and submission of timely and accurate information to the regulatory authorities
- Review and provide assurance of medical/pharmacovigilance content and clinical relevance of regulatory safety documents including Investigator Brochures, PSURs and ad hoc regulatory reports as assigned. This includes input to PSURs and PADERs with focus on providing overview for the medical analysis and safety sections.
- Work with labeling team to accurately portray the safety profile of assigned products
- Participate in the Pharmacovigilance Committee activities
- Maintain knowledge of global regulatory authority regulations (especially FDA and EU)
- Contribute to the training, leadership and continuing education for all departmental staff
- M.D. degree required
- Board certification in a specialty appropriate to the products of Jazz Pharmaceuticals preferred
- At least 5+ years of experience post-residency, with at least 3 years of experience in a pharmaceutical/biotechnology company
- Exposure to working relationship with the FDA, EMA and other regulatory authorities is preferred
- Knowledge and understanding of national and international regulatory guidelines preferred
- Knowledge of medical aspects of drug safety in pre- and post-marketing safety practice
- Knowledge of industry regulations and drug safety practices
- Experience with safety coding dictionaries (MedDRA, WHODRUG) required, experience with commercial databases preferred
- Excellent oral and written communication skills
- Excellent teamwork and interpersonal skills are required
- Strong skills in presenting drug safety topics for regulatory authorities, or at conventions, meetings, etc.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.