Dr. Irene Fermont, MD; MSc, EUQPPV
Owner of IFC – Irene Fermont Strategic Safety Consulting, Paris and Jerusalem,
Physician, Immuno-Hematologist, Master of Bioengineering, European Qualified Person for Pharmacovigilance (EU-QPPV) founding member of the QPPV association, coordinator of the Israeli Chapter of ISOP (International Society of Pharmacovigilance), founding member of the ISOP working group on risk communication
Irene’s successful career in the pharmaceutical industry stretches over 20years. She began her career in 1984 as Head of the Bone Marrow Graft Unit and Hemovigilance in the Blood Bank of Yvelines. She then created BIOFUSION, specialised in the conception of projects of blood bank turnkey units. In 1997 Irene joined LEO-PHARMA France as Head of Pharmacovigilance and Medical Information. In 2003 she was appointed Head of International Development by CETONIA. In 2004 Irene founded her own company, SHIELD-RM, providing specialised services in risk management to the pharmaceutical industry since 2004.. In 2005, as EU-QPVV, she undertook the organisation of Pharmacovigilance and Medical Information for ALEXION Europe and its subsidiaries. Among many others, she wrote a European Risk Management Plan for a monoclonal antibody and successfully participated in obtaining its marketing authorisation. She is specialized in Advanced Therapies risk management. Irene then acted as VP risk management & Pharmacovigilance at the ADDS,(CRO) building the Risk Management and Pharmacovigilance department from scratch with full outsourcing of Pharmacovigilance at global level. In 4 years the new department has recruited more than 30 Pharmacovigilance professionnals. Since 2013 she has created her own company IFC, acting as strategic consultant, and proposing as well a new activity : e–Vigilance, providing of all electronic tools for Pharmacovigilance, safety databases, e-transmission, e-reporting , e logbook, e-tracker under the leader ship of an electronic engineer.