Director of Global PV Vendor and Alliance Management
Category: Research & Development | Country: United States | State: California | City: Palo Alto | Type: Regular, Full Time | Job ID: 4210
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.
The Director, PV Vendor & Alliance Management will be responsible for
- He/she will provide high-quality pharmacovigilance expertise, strategic thinking leadership for vendor and business partner relationships contributing to the overall success of global safety surveillance of Jazz products
- He/she will manage a team of professionals who perform activities supporting good business relationships, vendor compliance monitoring, training and continuous improvement efforts
- He/she will be a member of the PV Leadership Team
- He/she will lead the PV Vendor & Alliance Management team.
The Director, PV Vendor & Alliance Management will be accountable for
- Partnering with vendors for resolution of safety operational issues and questions, identifying vendor training needs and opportunities for improvement, and ensuring implementation in collaboration with internal Jazz stakeholders
- Partnering with PV leadership to provide effective oversight, coordination and communication between Jazz and vendors/contracted partners, in support of compliant and high-quality delivery of pharmacovigilance-related services
- Partnering with leadership and staff of other Jazz departments to ensure service provider compliance with Jazz global PV reporting requirements when conducting projects and programs that may generate safety information relevant to Jazz marketed products.
- Effective oversight of outsourced operational activities, measuring vendor performance through Key Performance Indicators/Metrics according to Jazz standards and contracted Service Level Agreement(s)
- Stakeholder management & communication, including escalation of performance & delivery issues at vendor to functional management and/or governance committee(s)
- Implement robust vision and strategy for the PV vendor and business partner relationship management at Jazz that fosters internal and external commitment to shared goals for optimal performance for contracted safety services supporting the Jazz PV system
- Lead the PV Vendor & Alliance Management team including recruitment, training, mentoring and development.
- Collaborate with internal stakeholders in establishing/enhancing/aligning key performance metrics, training and processes related to interfaces with vendors and business partners.
- Partner with PV and other leaders to negotiate contracts, working processes, and project-specific documents
- Partner with all PV leaders to develop policies, processes and procedures regarding outsourcing strategies, implementation plans, adaptation methodology and operational in support of better PV vendor and business alliance management
- Oversee interactions with global vendors for rapid/proactive identification and resolution of PV-related questions and issues.
- Prepare and/or review relevant Jazz and vendor-controlled documents to ensure cross-functional/cross-company alignment and to ensure global PV requirements are met
- Perform financial responsibilities related to invoice approvals and accruals related to PV vendors
- Oversee the process for Vendor and Alliance Management to ensure Jazz remains in compliance with global PV regulation and guidelines while driving efficiency and quality
- Proactively identify opportunities to continuously improve process and operations between PV, other Jazz departments and vendors
- Represent PV at various business review / governance forums with vendors, communicating accountabilities, deliverables and achievement as appropriate
- Manage and provide budget oversight and forecasting for the PV Vendor and Alliance Management team
- Support EU QPPV in PV oversight and monitoring PV activities across the globe with regards to vendor relations
- Undertake additional projects, as assigned, in support of PV or other business goals.
Required Knowledge, Skills, and Abilities
- Prior experience in Pharmacovigilance at a senior level
- Experience in writing/reviewing contracts, work orders
- Experience conducting continuous improvement projects (e.g. Lean Six Sigma), developing SOPs, training material
- Extensive 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.
- Excellent oral and written communication skills
- Excellent teamwork and interpersonal skills are required with proven ability to effectively lead (multiple) projects and teams to successful conclusion
- Proven abilities in managing multiple, often complex and sometimes competing, objectives, goals and other priorities to effective and efficient conclusion
- Ability to work effectively within a matrix organization to achieve desired outcomes
- Ability to lead in a high pressure, fast paced and changing environment to ensure objectives are met on time and achieved with budget allocation
- Able to perform a variety of complicated tasks with a wide degree of creativity and latitude
Required/Preferred Education and Licenses
- 7+ years of experience within pharmacovigilance working with either a Pharmaceutical, Consultancy or Biotech business.
- Extensive business management experience with typically 3 years or more in a leadership role, or 5+ years in a role focused on vendor partnership/relationship management
- Health Care Professional Degree (e.g. RN, BSN, PA, NP, BPharm) or Life Science Degree (e.g. BSc Pharmacology, BSc Biology, BSc Neuroscience, etc.), or equivalent experience required
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.