Senior Pharmacovigilance Alliance Management Specialist

If you are a current Jazz employee please apply via the Internal Career site

Jazz Pharmaceuticals is a global biopharma 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, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

Job Description

Overview

Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.

We are looking for the best and brightest talent to join our team.  If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals. 

Position Overview

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 PVAs as well as effective contractual relationships with PV Service Providers.   

The PVAM Specialist is versed on Pharmacovigilance Agreements (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 agreemen