The Manager, PV Vendor & Alliance Management is responsible for supporting the activities performed within this group. This position assists the leaders of PV Vendor & Alliance Management in the effective oversight of outsourced activities, monitoring service provider performance and compliance with their contractual obligations. This position will interact with PQS staff, staff in other Jazz departments and with service providers performing activities supporting the global PV system.
- Coordinates Adverse Event reporting training to service providers supporting Jazz programs and PV review of associated program materials.
- Maintains inventory of PV-related service providers, contacts, contractual obligations and qualification status in Inova.
- Coordinates access to Jazz network and the global safety database for service provider staff, as appropriate.
- Supports collection of information required to update designated sections of the PSMF.
- Coordinates internal and joint governance meetings with service providers
- Collaborates with Global Case Management to ensure the key performance indicators (KPIs) and the key compliance indicators (KCIs) with regards to case management are meeting standards and contractual obligations.
- Supports monitoring service provider operational delivery (e.g., compliance with SOPs, quality standards, etc.), identifies opportunities for improvement (resource, process, performance) and supports change implementation in partnership with the service provider, PQS internal stakeholders, and other Jazz departments.
- Identifies program issues and areas of risk and escalates as appropriate.
- Works 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.
- Facilitates service provider on-boarding and ongoing training for products, data bases and SOPs and ensures service providers have access to all current reference materials appropriate to their remit.
- Prepares and/or reviews relevant Jazz and service provider controlled documents to ensure cross-functional/cross-company alignment and adherence to global PV regulations.
- Undertakes additional projects, as assigned, in support of Jazz PQS or other business goals.
Required Knowledge, Skills, and Abilities
- Knowledge of and experience with EU and US FDA PV regulations
- 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 oral and written communication skills, demonstrating professional maturity, confidence and competence
- Excellent teamwork and interpersonal skills are required with ability to effectively collaborate with internal and external contacts, building strong sustainable relationships
- 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
- Negotiating and influencing skills; ability to lead without authority
- Ability to work across cultures, including in a virtual environment
- Good conflict management/resolution skills
- Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)
- Proven ability to demonstrate Jazz values and leadership competencies
Required/Preferred Education and Licenses
- Health Care Professional Degree or Life Science Degree, or equivalent experience required
- A minimum of 3 years’ experience in pharmaceutical safety required; experience in a PV management role or in a role involving vendor partnership/relationship management responsibilities preferred
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.