Senior Physician in Drug Safety: Former Global Head of Drug Safety & PV at 2 major pharma companies; Author of textbook: Manual of Drug Safety & PV inscrit sur pharmacovigilance.enligne-fr.com

Résumé

25+ years in the pharma industry in clinical research & drug safety-global head of of PV at 2 major companies; author textbook: Manual of Drug Safety & PV; experience in ICH (1989-2004); experience in the USA & EU; dual US/French citizen...
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Présentation

US board certified in Internal Medicine and Gastroenterology. He graduated from the New York University School of Medicine with an MD and trained there in Medicine and Gastroenterology. He did a subsequent Hepatology post-doc at the Hôpital Beaujon/INSERM (Clichy, France). He was in practice at NYU-Bellevue Hospital before joining the pharmaceutical industry. He is a fellow of the American College of Physicians, the American College of Gastroenterology and the Faculty of Pharmaceutical Physicians. He is licensed in 3 states and on the staff at the NYU School of Medicine and UMDNJ. He has worked at Ives Laboratories (now Wyeth), Hoechst-Roussel Pharmaceuticals (now Sanofi-Aventis)...
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Spécialités

Head of global drug safety in industry; as a consultant: Organizational change & reengineering, SOP creation and rewriting; inspections & audits, risk management, drug safety white papers, regulatory intelligence, planning & strategy;crisis management; short or long term
Drug Safety & Pharmacovigilance
Quality & Compliance
Regulatory

Secteur activité

Pharmaceuticals, devices, biotech, IT