Kieran O'Donnell | Director
Independent PV Expert

After graduating in 1999 with an MSc Exercise Physiology, specialising in the Metabolic Syndrome, Kieran has spent ~25 years in drug safety with experience not only in both small and large pharmaceutical companies; but also in CROs and PV consultancy. Leading European and Global PV operations since 2006, Kieran has gained broad experience in PV QMS; Benefit-Risk management; Signal Detection & Management; PSURs & DSURs; RSI development; ICSR and SUSAR submission; Inspection (MHRA GCP & PV and FDA PV inspections; ISO 9001:2000; and responsible roles such as the RP for EudraVigilance and QPPV for Pharmacovigilance.  In addition to the completion of a PgC Pharmacovigilance from the University of Hertfordshire, Kieran is a member of the several industry associations including ISOP SIGs and the RQA PV Committee.