. Division of Pharmacovigilance Enter the email address you signed up with and we'll email you a reset link. An Introduction to Drug Safety Surveillance and the FDA Adverse Event Reporting System LTCDR Anne Tobenkin, PharmD Division of Pharmacovigilance Pharmacovigilance: Needs and Objectives Department of Pharmaceutical INTRODUCTION The under-reporting of adverse drug reactions is the major setback worldwide which may be attributed to the lack of time and report forms. 2 nd International Awareness Session - The EU medicines regulatory system and the European Medicines Agency Pharmacovigilance (PV) systems ensure the safety of medicine through efficient and timely collection, assessment, and communication of risks and To reduce their risks and increase their benefits. Sorry, preview is currently unavailable. 10/10/2013 Dept.