Manager, Process & Training, PV Compliance

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 follow @JazzPharma on Twitter. The Manager, Process and Training, Pharmacovigilance Compliance is responsible for ensuring consistency and compliance of procedural and training material across the Global Pharmacovigilance and Labeling (GPV&L) controlled document landscape. This role will work closely with GPV&L business process owners and the R&D Process and Training team stakeholders. The incumbent will strengthen and support GPV&L onboarding/orientation activities, implement processes to monitor/manage training compliance, and support the organization and maintenance of the GPV&L Business Continuity Plan. The role will also serve as a key contributor to elements of the PSMF, support PV related regulatory intelligence activities and as applicable, support other PV Compliance activities. Essential FunctionsKey contributor for the establishment, maintenance, and continuous improvement of processes for the collection, organization, and presentation of global PV process and training material and metricsTrack GPV&L Training compliance and accountable for implementing measures to support adherence to Jazz training requirementsSupport GPV&L Business Process Owners to ensure efficient and effective PV training is provided and documentedReview all GPV&L new/revised standards (SOPs/WIs/Guidance Documents/Training) to ensure consistency across the entire GPV&L controlled document landscape while ensuring GPV&L has clear, well documented processes and training materialCommunicates identified issues with GPV&L controlled documents to applicable PV functional leaders and leads/facilitates the resolution of the issueSupport the revision, implementation, monitoring, and testing of the GPV&L business continuity planCollaborates with GPV&L functional leaders to ensure compliance with Jazz standards and conventions for process and training activitiesResponsible for creating, maintaining and the continuous improvement of processes to strengthen and streamline PV new hire onboarding and orientationActs as a liaison with R&D Process and Training and GCM Process & Training TeamSupport (as determined by line management) PV process improvements including authoring/updating controlled procedures as it relates to compliance activitiesAssist in audit/inspection related activities, (pre-, peri- and post-inspection) and support audit/inspection readiness by maintaining a listing of PV proceduresParticipate in regulatory intelligence PV related activities and as applicable, lead/facilitate the implementation of PV related regulatory intelligence into impacted PV proceduresMake contributions to the PV System Master File (PSMF) per routine schedule, including but not limited to Module V and Annex ECreate and maintain a compendium of GPV&L standardsRemain current with global pharmacovigilance regulations and requirements, evaluate legislative changes affecting PV, and develop strategies to support the patient safety at the local levelRequired Knowledge, Skills, and Abilities Minimum 5 years business, pharmaceutical, or biotechnology industry experience.Knowledge of Good Pharmacovigilance Practices (GVP) is requiredGxP document management experience is requiredPV Compliance experience is beneficialPV Training experience is beneficialDemonstrated ability to lead multi-disciplinary projectsExcellent written and verbal communications skillsAbility to work in a fast-paced cultureSelf-directed and ability to take action as needed with limited oversightAbility to influence or gain acceptance from others in sensitive situationsAbility to work in a team environment and support stakeholdersAbility to work across geographical boundariesDisciplined, extremely detail oriented, and strong time management skillsRequired/Preferred Education and LicensesBachelor''s degree in business or life sciences requiredJazz 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.

Created: 2021-11-29