Profile: Expertise include improvement of your quality system in pharmacovigilance, management of pharmacovigilance audits at your company or at service providers, preparation of regulatory authorities’ inspections. Worldwide perimeter. Until end of August 2014 International Inspection Readiness & Liaison Head, Global Pharmacovigilance & Epidemiology, Sanofi. A pharmacist with over 25 years of experience in pharmaceutical industry, mainly at Sanofi. Her primary area of expertise was Pharmaceutical Science, then International Clinical Quality Assurance with a focus on Pharmacovigilance quality and compliance for the last 9 years including Pre-approval Inspections in Clinical field for New Drugs. Knowledge of the requirements and challenges of Pharmacovigilance at both corporate and at country level. Experience includes quality management for drug surveillance pre- and post-marketing activities. Clinical & Pharmacovigilance audit activities: rationale, planning, process, performance, and trending. Also, direct support to the preparation and hosting of pharmacovigilance inspectorate activity worldwide. Trainer at Paris Descartes University of Pharmacy for two graduates of University: Pharmacovigilance and Quality Auditor. Trainer at SafeSciMet at Paris South University of Pharmacy: Course 5.2 Clinical safety post-approval, in framework of «European Modular Education and Training Program in Safety Sciences for Medicines. She was also registered as Quality Management System (QMS) ISO 9000 Lead auditor in International Register of Certified Auditors (IRCA). Had the opportunity to audit for PV or clinical trials, also hosting regulatory PV (mainly) or Clinical inspections for some: France, UK, Ireland, Germany, Italy, Switzerland, Belgium, Luxembourg, Netherlands, Denmark, Sweden, Hungaria, Romania, Poland, Ukrainia, Croatia, Greece, Turkey, Malta, CZ Republic, Portugal, Taiwan, Hong-Kong, Singapore, Japan, Australia, Korea, USA, Brazil, Argentina, Canada. Languages Known: English. French. Based in Greater Paris Metropolitan Region.