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.

Mr Scheiner started his career lecturing Database Design and Database Management at the University of Technology, Sydney (1997-2000). Since then stayed in ICT technical and leadership roles in private sector and EU regulatory agencies, including EMA where he led the technical development of EudraGMP, EUTCT, EU Clinical Trials, ISO-IDMP and others. He has always focused on implementing complex data pipelines starting from data collection (mostly EU-wide), evaluation, processing, analytics as well as learning from the data.

Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including technology, processes, and relevant aspects of Pharmacovigilance Legislation. He is now accountable for Patient Safety Monitoring across medicines, vaccines, devices, defects and blood products. Phil was responsible delivery of MHRA systems for COVID-19 vaccine surveillance and their integration into the healthcare system. For several years he has led international projects to develop and deliver tools for global pharmacovigilance.