Brief Description: The Manager, Clinical and Pharmacovigilance Quality Assurance for Pharmacovigilance (PV) system is a significant contributor to Global Quality and is responsible for coordinating activities to regularly verify that Jazz PV system Vendors, commercial partners and Jazz Global R&D/Quality and other teams are operating in line applicable regulations, industry standards, Jazz policies, procedures, and quality standards in support of the Quality Management System & PV system.
In addition, the Manager will support Global Quality/ R&D leaders in providing strategic input and tactical implementation for pharmacovigilance system activities and projects, identify and communicate compliance risks, oversee action plans to mitigate risks (if applicable), and be actively involved in inspections and inspection-readiness activities. This person will participate in interdepartmental teams meetings and at times may be asked to perform activities to support other GxP areas, quality operations, and global quality systems.
Essential Functions Gain and maintain professional expertise and knowledge of local and international regulations relative to pharmacovigilance system and qualityContribute to the execution of Global PV system audit strategy, and implementation within the Quality Management SystemPerform reviews on internal and external SOPs; participate in the development of SOPs for Quality or PV System stakeholdersSupport updates of the quality related sections in the Pharmacovigilance System Master File (PSMF) or similar documentsPerform execute and evaluate PV-System auditee risk assessmentsCoordinate and implement strategic audit plans for pharmacovigilance system activities that include service providers, vendors, business partner, and internal audits.For pharmacovigilance system audits conducted directly by Jazz personnel or conducted by a vendor on behalf of Jazz (external audits) participate as auditor/co-auditor and/or manage the relationship with the vendor.Present QA findings/observations to in-house staff and, if appropriate, to the responsible service provider, vendor, or partner company.Contribute to the evaluation of corrective and preventative action (CAPA) findings to identify quality-related signals and trends for improvement; ensure adequate and timely closure of CAPAs generated from audits.Participate in inspection readiness and inspections as assigned. May perform one or more inspection roles during an inspection (e.g. inspection readiness training, runner, scribe, backroom lead, SME preparation, QA checks, etc.)Identify and escalate critical quality issues to senior Quality managementContribute to the development of continuous quality process improvements and the identification of identifying root causes for investigations and effectiveness checks if appropriateRepresent CPVQA within interdepartmental teams / project groups and innovation projectsMaintain current training in accordance with the training curriculumThis position may require up to 30% travelRequired Knowledge, Skills, and Abilities Established Pharmacovigilance or Quality professional Strong GVP knowledge & expertiseExcellent written and verbal communications skillsAbility to work in an entrepreneurial and fast-paced culture.GVP auditing experience is preferred.GVP lead auditor certification is desirable.Self-directed and ability to take action as needed with oversight.Ability to collaborate and partner with various internal and external business partnersAbility to work in a team environment.Disciplined, detail orientated, and strong time management skillsKnowledge of post-authorization commitment requirements is preferred (Phase IV, PASS Studies) and Managed Access Programs (PSPs/MRPs, Early access etc.) is desirable.Knowledge and experience with GCP, GLP, and GDP is a plus.Inspection experience with FDA, MHRA (or other EU Competent Authorities); experience with emerging markets Regulatory Authority such as PMDA a plus.Required/Preferred Education and Licenses Bachelor's degree in a related field is required; Master's degree in management, leadership or scientific discipline a plus.
#J-18808-Ljbffr