Senior Industry Leader
Heather Murphy RN, MBA, CQA
Heather has over 20 years’ experience in Pharmacovigilance with expertise in the PV Operations and PV Audit areas. Her PV experience includes the establishment of PV departments for companies without existing departments and the reengineering of PV departments for companies in various stages of transition. She has successfully designed and implemented PV systems for small to large size companies in preparation for US and global product launch. The PV Operations activities have ranged from the strategic to tactical with experience in PV inspections with the FDA, EMA, Health Canada, MHRA, ANSM, BfArM and Swiss Medic. PV audit experience includes business partner, vendor, CRO, REMs, and internal PV department audits.
Heather is the author of “A Guide to Pharmacovigilance Audits in the USA”. Springer Nature, 2024. https://link.springer.com/book/10.1007/978-3-031-73596-7. This book provides practical guidance for auditors in regard to what questions to ask, what information to look for, and what documents to request during Pharmacovigilance (PV) audits to ensure the auditee Pharmacovigilance System is compliant with regulations, contractual requirements and industry best practice. This is an ideal book for auditors and auditees who want to obtain practical PV auditing skills.