Physician and pharmacovigilance leader with more than 26 years of experience as a senior regulator, QPPV, auditor, trainer, and serial entrepreneur. Working in intelligent automation in PV for over 10 years, with the last 4 years dedicated to hands-on development and implementation of generative AI and AI agents in PV operations, including the validation of such systems and their defence before auditors and inspectors. Faculty member of DIA’s AI in PV training course and lecturer at the European Course in Pharmaceutical Medicine. Fellow of the International Society of Pharmacovigilance. Educated at Charles University in Prague, Imperial College London, with additional executive education in business and agentic AI from Harvard and MIT.