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.

The Director, Pharmacovigilance Alliance Management (PVAM) is responsible for overseeing and optimizing the value of Jazz PV alliances. Reporting into, and under the direction of the Executive Director PV Operations, this highly experienced Pharmacovigilance leader will be responsible for setting the standards for Pharmacovigilance Agreements (PVA)s, Safety Data Exchange Agreements (SDEAs), and PV Service Provider Agreements worldwide to ensure PV support for activities in strategic functions of the business, ensure high quality safety data to enable protection of patients taking Jazz medicines, and ensure compliance with worldwide Regulations and Jazz obligations to Business Partners.

The PVAM Director supervises and directs the operational and management activities of multiple Managers and their teams in the effective oversight of SDEAs, PVAs, Safety Reporting Plans (SRPs), PV Service Provider Agreements, and is accountable for internal and external customer relationships, managing these alliances directly and working with the PVAM Team as well as in partnership with cross-functional staff.

The PVAM Director will liaise with cross functional customers and stakeholders within Jazz to proactively ensure nuance stakeholder requirements are met, and key safety performance indicators are defined and met, as well as to evaluate opportunities to maximize the value proposition of outsourced PV services and Business Partner Agreements. The leader will work closely with others across Pharmacovigilance and the strategic functions of the business.

Essential Functions

• Manages direct reports in the PVAM team as required including performance management, staff development plans, forecasting and resource planning, and succession planning.
• Provides expertise, leadership, and direction to the PVAM team, and participates as a member of PV Operations LT to inform strategic decision-making pertaining to PVAM team and the department
• Partners with the Executive Director PV Operations to establish the strategy for the PVAM team that is aligned with the PV Operations department and Global Pharmacovigilance organization strategies, as well as long and short-term goals
• Implements the strategy for PVAM section
• Oversees and ensures qualified Business Process Owners for PVAM related procedural documents.
• May be a signatory for SDEAs or delegate for the Executive Director PV Operations
• Fosters productive working relationships with internal and external PV alliances supporting Jazz PV
• Oversees and ensures effective management of business partner and service provider relationships to ensure collaboration and compliance with SDEAs, PVAs and PV Service Provider Agreements
• Oversee and ensure effective and active governance model design and implementation for outsourced PV Services contributing to overall success of outsourced investments
• Ensure effective oversight of non-PV service provider compliance with Jazz global PV reporting requirements when conducting projects and programs that may generate safety information
• Collaborate with internal stakeholders in establishing/enhancing/aligning key performance metrics, training and processes related to interfaces with service providers
• May Lead internal and joint governance meetings with PV service providers
• Ensure and oversee the establishment and maintenance of infrastructure to disseminate key information regarding responsibilities and obligations from the SDEAs to relevant staff, including the use of SDEA management tools & systems/applications
• Ensure and oversee the maintenance of a global perspective of the business need for accurate, high-quality SDEAs, PVAs and PV Service Provider Agreements in a cost-effective manner, while maintaining regulatory and internal procedural compliance
• Delivers high-quality and timely inputs in support of PV Operations department business plans and priorities
• Continuously assesses and maintains in-depth knowledge of Pharmacovigilance regulations in major markets
• Ensures and oversees awareness of and compliance with PV Service Provider Agreements, PVAs and SDEA terms and obligations by accountable functions across Pharmacovigilance, and ensures corrective and preventive actions are taken in the event of non-compliance
• Participates in due diligence and Business Development activities (as requested) and ensure and oversee subsequent implementation actions
• Participates in Business Partner audits (of Jazz or by Jazz)
• Active involvement and support of the review and maintenance of Inter-Company Agreements, in collaboration with other relevant stakeholders
• Collaborates with other departments to ensure appropriate collection and handling of safety data
• Ensures and oversees a state of inspection readiness in the PVAM team
• Serves as subject matter expert in discussions during Inspections
• Contributes to the maintenance of the Pharmacovigilance System Master File, as requested
• Oversee ongoing and ad-hoc projects in the PVAM team, delegating tasks according to skill level
• Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes
• Collaborates with senior staff in the PV Operations department to achieve the objectives of the Department
• Other duties as required to support PV Operations

Required Knowledge, Skills, and Abilities

• Comprehensive working knowledge of Global Pharmacovigilance Regulations including but not limited to FDA, EMA, MHRA, PMDA, Health Canada and ICH guidelines
• Experience in managing CRO/business partners/distributors/contractors/vendors
• Uses broad expertise or possess unique knowledge and skills to contribute to the development of measurable goals & objectives and working principles to achieve goals in creative and effective ways
• Business acumen
• Able to work with a high degree of autonomy in a fast-paced environment
• Experience working with Global teams and cultures
• Demonstrated leadership and professional skills, ability to resolve conflict
• Demonstrated record of professional excellence – background of high professional achievement and motivating others in this
• Ability to influence while maintaining independent and objective views
• High ethical standards and commitment to Jazz values & behaviors
• Project management experience preferred
• Knowledge of the end-to-end drug development and commercialization process preferred
• Must be self-motivated, detail-oriented and have strong ability to multi-task.
• Must possess excellent communication (oral and written) and complex problem-solving skills.
• Must have strong leadership, interpersonal/organizational skills.
• Flexibility to work outside of normal working hours or on-call arrangements.
• Must have strong interpersonal/organizational skills as well as a team oriented approach
• Strong computer skills in drug safety applications, Word, Excel, and Power Point

Required/Preferred Education and Licenses

• BS/BA degree in health science field or related discipline with a minimum of 8+ years of direct drug safety and pharmacovigilance experience;
• Minimum 2+ years people management (direct reports) or 4+ years of leading project teams (no formal direct reports but responsible for leading teams with project deliverables).
• MBA a plus
• Lean Sigma a plus
• Project Management a plus

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.

FOR US-BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $176,000-$231,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits