Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

Head of Global Pharmacovigilance Operations – Executive Director

This leadership position reports in the VP Global Pharmacovigilance and Labeling (GPVL). The head of Global Pharmacovigilance Operations (GPVO) is accountable for the delivery of safety data reporting responsibilities owned by the Global Pharmacovigilance Operations (GPVO) team and for compliance across GPVL. As such, this role will oversee the leadership team responsible for global case management, alliance management, safety agreements, safety systems and GPVL compliance.

The Head of GPVO develops and maintains the GPVO organization in accordance with good pharmacovigilance principles, regulatory requirements, business needs and responsible budgeting principles. The Head will also assure the regular review of KPIs and metrics across GPVL department, with the goal of assuring compliance and inspection readiness.

The Head of GPVO, working through the GPVO leadership team, has oversight for Jazz employees, contract vendors and functional service providers. The Head will assure appropriate training and development for all staff in GPVO, as well as for vendors and service providers.

The Head of GPVO will regularly engage in projects and collaborations with other Jazz groups to optimize the receipt, processing and submission of safety data. Key partners include but are not limited to other teams in GPVL, Regulatory, Clinical Development and Medical Affairs, Global Quality, Information Services, Legal affairs, Procurement and Commercial and Marketing.

The Head of GPVO is committed to the Jazz values of Integrity, Innovation, Pursuit of Excellence, Passion and Collaboration.

Essential Functions

• Optimizes and maintains the organizational structure with GPVO to support the obligations of the PV operations department
• Establishes and oversees the business processes required to assure that Jazz is compliant with all requirements for safety data reporting for all Jazz products in clinical development and post approval to regulatory authorities, including marketing research and digital information streams through:
  • Global Case Management
  • Safety Systems Management
  • Alliance Management
  • Vendor Management
  • Safety data exchange agreements
  • Compliance management
• Supports compliance activities with the labeling and medical safety branches of GPVL by assuring training, maintaining metrics and KPIs and review
• Assures high quality, timely submissions of individual case safety reports
• Assures connectivity with key partners to assure the collection of safety data from all sources and to optimize business processes within Jazz.
• Assures appropriate training:
  • vendors, contractors and functional service providers performing GPVL functions
  • Jazz employees in GPVL and other teams handling safety data
• Contributes to the Jazz Quality Management System (QMS), and assures that GPVL department is aligning with QMS requirements, including good document management practices
• Model and encourage adherence to the Jazz Values and Mission.
• Coach and mentor staff including direct reports ensuring appropriate levels of accountability for delivering according to Jazz core competencies and values.
• Active member and participant of the PV leadership team collaborating with other members to ensure GPVL delivers its objectives in alignment with R&D objectives and Corporate objectives.
• Measure performance through defined performance, quality and compliance metrics in partnership with Jazz Global Quality.
• Assures the appropriate SOPs, guidelines, and processes are in place to deliver the activities across the department.

Required Experience and Education

• 10 years of pharmacovigilance experience in Pharmaceuticals focused company
• 5 years leadership with demonstrated success in building and leading teams and driving performance within a team environment
• Health Care degree preferred, RN, Pharm D or PhD in life sciences; Masters level degree with appropriate experience will be considered.

Required Knowledge, Skills, and Abilities

• Highly self-motivated, resilient and achievement-oriented, with the ability to succeed in an environment that demands fast but well-founded decision-making on a vast number of multidisciplinary issues
• Excellent understanding of Pharmacovigilance regulations, compliance guidelines and complexities concerning this function.
• Excellent leadership, people management, project management, and process improvement abilities. Excellent oral and written communication skills, and attention to detail.
• Robust understanding of safety database system Argus, performance metrics
• Strong understanding of budget and vendor management
• Ability and willingness to travel both domestically and internationally on periodic basis.

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.