This position will be responsible for leading the global Pharmacovigilance & Risk Management organization. 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 pharmacovigilance, drug safety, case management and risk management teams for investigational and marketed products, ensuring compliance with global regulations, compliance with company policies and procedures, and overseeing the assessment of the safety profile of all products, signal detection and the mitigation of potential safety risks.
- Leads and directs all aspects of pharmacovigilance and risk management activities for investigational compounds and marketed products
- Oversees and ensures that pharmacovigilance systems continuously monitors and evaluates 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.
- Manages internal team of permanent staff and contractors to ensure delivery of quality safety and pharmacovigilance services including managing performance, goal development and accomplishment, application and adherence to corporate values and core competencies.
- 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.
- MD/DO, PharmD, Physician Assistant degree 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.
- Occasional public contact requiring appropriate business apparel.
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.