Job Overview
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate and transform the lives of patients. We are dedicated to developing life-changing medicines for people with serious diseases often with limited or no therapeutic options.
The Manager, Clinical and Pharmacovigilance Quality Assurance (CPVQA) plays a significant role in ensuring that our PV system operates in line with applicable regulations industry standards Jazz policies procedures and quality standards.
Key Responsibilities
• Gain maintain professional expertise knowledge of local international regulations relative to pharmacovigilance system quality.
• Execute Global PV System audit strategy implementation within Quality Management System.
• Perform reviews on internal external SOPs; participate in development of SOPs for stakeholders.
• Support updates of quality related sections in Pharmacovigilance System Master File PSMF documents.
• Execute evaluate PV-System auditee risk assessments coordinate implement strategic audit plans for pharmacovigilance system activities involving service providers vendors business partners internal audits.
Additional Responsibilities:
p>For direct or vendor-conducted audits ensure adequate timely closure CAPAs generated from inspections perform one multiple inspection roles during an inspection. Identify escalate critical quality issues senior management contribute continuous process improvements root cause investigations effectiveness checks as assigned represent CPVQA interdepartmental teams project groups innovation projects