This opportunity is available in Palo Alto, Ca, Philadelphia, PA, Dublin, IE, and Oxford, UK
This position will be responsible for leading the global Medical Safety team. This is a strategic leadership position with direct report responsibilities across multiple locations in the United States and Europe. This leader will provide strategic leadership, people leadership and medical oversight for individual case safety report medical review, safety assessment, and maintaining the safety and risk profiles of investigational and marketed products, ensuring compliance with global regulations, compliance with company policies and procedures, and overseeing the safety signal process and the mitigation of potential patient safety risks.
This is a high-visibility leadership position which requires excellent communication to influence and have a meaningful impact on matrix teams.
- Leads and directs all aspects of the medical safety for investigational compounds and marketed products
- Executes through leaders and team members to evaluate safety data relevant to all products (marketed and investigational), to characterize their benefit-risk profile and to anticipate and mitigate safety risks.
- Directs the development and preparation and ensure timely submission of regulatory safety reports (e.g., Developmental Safety Update Reports, Pharmacovigilance Safety Update Reports, and expedited safety reports), investigator communications, product labeling/package inserts, and other reports including reports for company management.
- Leads an internal team of permanent staff and contractors to execute according to corporate values and core competencies by instill trust through effective and transparent communications.
- Provides ongoing updates to senior leadership on changing risk-benefit profile of company drug products.
- Sets departmental goals, objectives and budgets to effectively meet corporate objectives.
- Monitors industry best practices and changes in global safety regulations and guidelines.
- Participate on the PV Quality Council, Labeling Committee, Safety Management Teams, PV Leadership Team, and Executive Safety Board.
- Participates in departmental activities to ensure internal audit and regulatory inspection readiness
- Contributes as a subject matter expert to departmental process improvement initiatives
- May perform critical and strategic review of safety data in support of ad hoc safety data review.
- May need to participate in due diligence activities as requested.
- M.D. / D.O., with a minimum of 10 years of related industry experience. Related experience should include 7 or more years of management level international activities, experience in direct interaction with key regulatory agencies (US and non-US)
- 5 or more years of management experience in a matrix/geographically dispersed organization.
- Demonstrated excellent organizational and planning capabilities
- Excellent critical data analysis skills
- In-depth knowledge of pharmacovigilance regulations including, EU PV legislation, FDA requirements, international guidelines (ICH/CIOMS) with experience in their practical application.
- In-depth understanding of pharmacovigilance processes, regulatory compliance and standardization. In-depth knowledge of risk evaluation and mitigation strategies (REMS) and risk management program (RMP) systems.
- Expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities
Description of Physical Demands
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
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.