Free Lance Consultant
Since October 2009
independant Consultant : operational aspects of Pharmacovigilance activities. certified for eudravigilance icsrs reporting and xevmpd. glaxosmithkline biologicals, boehringer-ingelheim, thrombogenics, novo-nordisk besins,...misc. cros
Independant consultant : operational aspects of pharmacovigilance activities. Certified for Eudravigilance ICSRs reporting and xEVMPD. GlaxoSmithKline Biologicals, Boehringer-Ingelheim, Thrombogenics, Novo-Nordisk Besins,...Misc. CROs
Head case management group - Biologicals Clinical Safety & PharmacovigilanceAugust 2007 --- September 2009
staff of 30 people : overall responsibility of case management activities (pre and post registration) including Data entry, data reconciliation, resource Forecasting and Outsourcing, Compliance with applicable laws and regulations (emea, FDA, ich, gcp) Quality Assurance, safety data exchange agreements, active participations to inspections & responses to findings (FDA, bha) , review of sops and establishment of working documents,…
Manager case management group (post marketing case handling)- Biologicals Clinical Safety & PharmacoSeptember 2006 --- July 2007
9/2006 - 07/2007: manager case management group (post Marketing case handling)- biologicals Clinical safety & Pharmacovigilance management of post Marketing Data entry group (5 people) including all Data entry activities (spontaneous cases, post Marketing surveillance, literature), data base searches (periodic reports, product complaints, ad hoc queries), expedited reporting (e2b), resource Forecasting, guidance documents, participation and responses to audits.