Manager, PV Alliance Management - Remote
Dublin, Ireland; Palo Alto, California; Oxford, United Kingdom; Philadelphia, Pennsylvania; New York, New York; Boston, Massachusetts; London, United Kingdom; Lyon, France; München, Germany
Research & Development
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 PV Alliance Management (PVAM) Manager plays a key leadership role in the PVAM Team, facilitating across functional teams, taking ownership of and leading external service provider 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 Manager is accountable for 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 Manager may lead cross- functional matrix teams and takes ownership of external PV Service Provider relationships.
The PVAM Manager is versed on Pharmacovigilance Agreements (PVAs), PV Exhibits (PVEs)/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. If/as assigned, the Manager negotiates and maintains Agreements with PV Service Providers, and is responsible for leading vendor governance meetings, maintenance and reporting of KPIs/SLAs, and monitoring and proactively ensuring the health of relationships is robust. The PVAM Manager may also support delivery of strategic Business Development and Business opportunities. The PVAM Manager will assist in special projects as assigned by the Pharmacovigilance (PV) department management.
The PVAM Managers have a breadth of responsibilities which are prioritized within the PVAM Team, and may be assigned to:
Global PV Vendor Services
Regional PV Vendor Services
Business Development & Opportunities
PVAM Manager 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.
Lead the implementation of new external service provider relationships and manage maintenance/change
Lead the establishment and maintenance of PVAs/SRPs/SPOPs/WOs associated with new business initiatives and opportunities.
Lead discussions with business process owners for additional information to address questions in establishing a PVA/SRP/SPOP/WO.
Lead the close-out of PV Service Provider relationships
Act as the lead for PV Service Provider relationships, including maintenance of applicable SPOPs, leading governance meetings, oversight of KPIs/SLAs, ownership of budget as applicable and ownership of relevant agreements and project documents.
Provide regular updates on status to AD PVAM, and monthly KPI/SLA reporting to Head of PVAM/CM/SDEA PV section
Oversee the PVA/SRP review & negotiation of the agreement.
Oversee coordination of PV activities associated with in/out-licensing and marketing authorizations/withdrawals in Canada and United States.
Establish and strengthen relationships with 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.
Identify opportunities for improvement (resource, process, performance) and affect change, driving implementation of opportunities and mitigating risks in partnership with the PV Service Provider and internal Jazz stakeholders.
Identify program issues and areas of risk and escalate as appropriate.
Work with service providers for resolution of operational issues and questions, identifying training needs and opportunities for improvement and supporting implementation in collaboration with internal Jazz stakeholders.
Prepare and/or review relevant Jazz and service provider controlled documents to ensure cross- functional/cross-company alignment and adherence to global PV regulations.
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.
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. Follow up with meeting participants on the resolution of action items from meetings.
Conduct ad hoc/special projects and analyses for PVAM leadership.
PVAM Manager 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
May have line management responsibility
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.
PVAM Manager: Minimum Requirements
BS/BA degree in health related or biological science related field
A minimum of 4 years’ experience in pharmaceutical safety required with a minimum of 1 year of experience in a PV management role or in a role involving vendor partnership/relationship management responsibilities preferred
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
Good conflict management/resolution skills.
Proven ability to demonstrate Jazz values and leadership competencies
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 Employer.