Caroline Fitzsimons

Caroline serves as the Associate Director of QA Pharmacovigilance at Jazz Pharmaceuticals, leading the organisation’s Pharmacovigilance Quality Assurance (GvP) function, with responsibility for ensuring regulatory compliance, inspection readiness, and data integrity across all global PV activities. She holds an MSc in Science from University College Dublin and began her career in clinical research, initially specialising in Data Management before transitioning into Clinical Research Operations. Over a 12‑year period, she worked as a CRA and CRM across multiple therapeutic areas and trial phases in Ireland and the United Kingdom. Caroline has held leadership roles spanning Global PV Agreements, Quality Management, and Local QPPV operations. Her expertise includes regulatory inspections, inspection readiness, deviation management, PV systems oversight, and PSMF coordination. She is recognised for her strategic approach to quality governance and her ability to build and lead high‑performing teams. Based in Dublin, Ireland, Caroline lives with her husband and two adult children. Outside of her professional commitments, she enjoys reading, sea swimming, photography, live music, long walks, and travel.