Worked in Pharmacovigilance for over 17 years, initially at GSK in the UK, followed by nine years at Amgen in the US including roles as Head of Safety Operations and Head of Regulatory Operations prior to joining Sciformix in 2015. Managed significant global changes in safety processes to improve overall business efficiency including the development of an electronic interface for serious adverse event collection in clinical trials and the implementation of a new safety system. Experienced in developing flexible business models while ensuring compliance and quality delivery.

Dr. Lungu has over 30 years of experience in pharmacovigilance and regulatory compliance. He has conducted 180+ PV audits for pharmaceutical companies and EU authorities, advised on PV system improvement, and supported EU inspections. Since 2004, he has been an official EMA EudraVigilance trainer, delivering 300+ global courses, and has served as EMA master trainer for the Clinical Trials Information System since 2021. He continues to train and support EVDAS use for MAHs. Dr. Lungu earned his MD from the Free University of Brussels in 1992.

Dr Mangesh Kulkarni is a Post Graduate Physician MD with 23 years of experience in Pharma R&D and Medical Affairs from diverse set-ups such as MNC Pharma, CRO, Academia and IT industry. He has handled various leadership roles at the functional, operational and business consulting levels for large scale global business units/functions. In his current role, he heads the Global Pharmacovigilance at Tata Consultancy Services.