As Head of Global Vigilance Operations, Sophie is responsible for managing the Vigilance Team to ensure a high level of client service is maintained. One of the key elements of this role is developing and enhancing the vigilance capabilities and services for clients.
Sophie’s broad PV experience comes from working in Contract Safety Organizations (CSO) dedicated to Pharmacovigilance and Medical Information since 2006. During this time, Sophie has had the opportunity to be deeply involved in the PV and Medical Information management of more than fifty different clients, with various portfolios such as generics, orphan drugs, antidotes, woman health, consumer health. She acquired an extensive knowledge of the regulations in force (ICH, GVP, BPPV) and of the Authorities expectations in each context.
These 16 years of deep involvement with each client and the QPPV/LPPV roles she assumed on their behalf gave her a good understanding of the Pharmaceutical Companies’ constraints and needs. The different audits (>100) and inspections (>10) she attended in this context reinforced her appetence for Quality Management System and her rigor.
In addition, her former positions as Quality Director, then Chief of Operations and General Manager for AxPharma, honed her ability to organize and enhance the functioning of a multidisciplinary team.
Sophie completed her Degree in Pharmacy at the Université Aix-Marseille, after which she obtained a University Degree in “Pharmacovigilance and drug safety” at Université Paris V, then lastly completed a General Management Degree at the EM Lyon Business School.
Sophie is connected to our Boulogne office, in France.