Expert in Pharmacovigilance and Drug Safety. European Medicines Agency (EMA) scientific administrator responsible for performing signal management activities for centrally and nationally authorized products, providing support to (Co)- Rapporteurs and Scientific Committees and contributing to scientific projects in the area of pharmacovigilance and signal management. EMA Emerging Safety Issues (ESIs) coordinator and responsible for the EU-NTC PhV Training Curriculum design, implementation and its maintenance.

PV professional with immense experience with critical PV processes gained through execution as well as its successful leadership and management. The key areas of Jan’s expertise are strategic consulting on full PV outsourcing including expert advice and guidance on the implementation of AI-powered safety systems, Safety data mining in global databases, ICSR Management, EV and XEVMPD maintenance, EU QPPV activities, signal management, PSMF development/maintenance, medical writing, and audits/inspections.

Dr. Lungu has over 30 years’ experience in drug development, clinical research, Pharmacovigilance and quality assurance. He conducted more than 160 Pharmacovigilance quality system audits in more than 40 countries around the globe. Apart of audits, he is a dedicated trainer of the official EMA EudraVigilance and XEVMPD training programmes and led over 300 offerings since 2004.