Pharmacovigilance Alliance Management Specialist

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 and on Twitter.

The PV Alliance Management (PVAM) Specialist plays a key role in the PVAM Team, facilitating across functional teams, building relationships, and supporting the delivery of high quality PV Agreements to ensure timely and accurate collection, safety review, processing and reporting of adverse event data in compliance with applicable global regulations and Jazz Pharmaceuticals standard operating procedures and guidelines. To this end, the PVAM Specialist guides and facilitates effective working relationships within R&D Global Pharmacovigilance and Labeling, and cross-functionally with strategic departments within the company and its affiliates/subsidiaries to foster smooth, accurate, and timely flow of activities related to PV Agreements (PVA)s as well as effective contractual relationships with PV Service Providers.

The PVAM Specialist is versed on PVAs, Safety Reporting Plans (SRPs), PV Service Provider Agreements, and acts as key contact person for internal and external customers, managing these alliances directly and working with the PVAM Team as well as in partnership with cross-functional staff. Working with the PVAM Manager, the Specialist may negotiate and maintain Agreements, including maintenance and reporting of KPIs/SLAs and participate in vendor governance. The Specialist will be responsible for coordinating PV activities related to Global Expansion in Canada and US. The PVAM Specialist may assist in special projects as assigned by the Pharmacovigilance (PV) department management.

The PVAM Specialists have a breadth of responsibilities which are prioritized within the PVAM Team, and may be assigned to:

• Business Development & Opportunities
• Global PV Vendor Services
• Regional PV Vendor Services

PVAM Specialist responsibilities may include PV alliance activities such as, but not limited to:

• Serve as the liaison between Global Pharmacovigilance and cross functional organizations, acting as a Pharmacovigilance ambassador and domain expert as well as increasing awareness within Global Pharmacovigilance of cross-functional customer/stakeholder needs and dependencies, including PV Service providers.
• Support implementation for new partnerships and maintenance/change
• Support establishment and maintenance of PVAs/SRPs/SPOPs/WOs associated with new business initiatives and opportunities.
• Interact with business process owners for additional information to address questions in establishing a PVA/SRP/SPOP/WO.
• Coordinate the PVA/SRP review by the safety review team, summarize agreement comments, and participate in the negotiation of the agreement.
• Contribute to resolving conflicts at team level or higher and facilitate decision making within the team. Escalate issues utilizing governance models and standard communication plans.
• Coordinate implementation of Safety Reporting plans for programs with the potential to generate safety information.
• Coordinate PV activities associated with in/out-licensing and marketing authorizations/withdrawals in Canada and United States.
• Collaborate with the cross-functional groups that have responsibility for activities that may generate adverse events or safety information such as (not limited to) Business Alliance/Development, Commercial, Medical Affairs.
• Support collection of information required to update designated sections of the PSMF.
• Organize and moderate meetings and author minutes/discussion summaries. Solicit items for and set agendas. Send out draft minutes/summaries for comments to both internal Global Pharmacovigilance and external PV Service Providers, and distribute final summaries to all participants, as well as senior PVAM staff. Follow up with meeting participants on the resolution of action items from meetings.
• Maintain and organize internal PVAM files (Agreements, supporting documents, meeting minutes).
• Participate in maintaining PVAM Jazz Portal and Mailbox.
• Conduct ad hoc/special projects and analyses for PVAM management.
  
  PVAM Specialist Essential Functions

• Adheres to company templates and GxP guidelines for documentation and communications
• Ensures compliance with corporate and departmental policies, standard operating procedures, and timely completion of all assigned training
• Other duties as required to support PVAM team
• Participate in the development and maintenance of PVAM activity workflow processes, department policies, work instructions, standard operating procedures and training material when new and/or updated processes are introduced
• May serve as an individual contributor or a project manager for functional projects or workflows.
• May mentor other team members
• Participation in Inspections and Audits as identified, as well as active role in maintaining a business as usual inspection ready state of operating
• Takes responsibility for personal development and continuous improvement including keeping up to date with pharmacovigilance practices, legislation and guidelines.
• Work collaboratively with cross-functional teams to evaluate the performance, identify bottlenecks, minimize regulatory risks and recognize patterns of inefficiencies in current operational processes
• Collaborate effectively with Quality Assurance, Legal, and Project Management.
  

Minimum Requirements

• BS/BA degree in health related or biological science related field
• 3 plus years of pharmaceutical drug safety/pharmacovigilance operations experience
• In depth knowledge of pharmacovigilance activities and processes, with a preference for experience in more than one PV functional area
• Knowledge of current and emerging regulatory requirements and expectations including EMA GVP Modules, FDA IND and NDA reporting requirements, global risk management requirements, ICH, CIOMS.
• Experience interacting with service providers or external business partners
• Excellent teamwork and interpersonal skills are required with ability to effectively collaborate with internal and external contacts, building strong sustainable relationships
• Excellent oral and written communication skills, demonstrating professional maturity, confidence and competence
• Ability to work effectively within a matrix organization to achieve desired outcomes
• Track record of effective decision-making; makes good business decisions and analyses problems from multiple perspectives
• Ability to work across cultures, including in a virtual environment
• Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)
• Team Building, Motivating and Influencing Others without authority
• Promoting Innovation and Process Improvement Maintaining activities

• Negotiation skills Strong analytical skills Must demonstrate accountability for delivery of results and have good problem-solving and decision-making skills
• Must be able to manage their own work, with ability to prioritize, plan and organize work assignments while working under strict timelines

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.