Introduction

The etymological roots of Pharmacovigilance (PV) are based on the Greek “pharmakon” (drug/medicine) and the Latin “vigilaire” (keep awake). The goals of PV are rather broad and wide-reaching. A summary of some of the main goals is listed below: Pharmacovigilance activities are multifaceted and vary depending on product requirements as well as regional and global regulatory requirements. Each organization may manage these activities internally, outsource to an external vendor, or utilize a hybrid approach. In addition, depending on the size of the organization, PV activities are most commonly managed by a separate PV department, but it is not unusual to see some PV activities managed through other departments (e.g., FDA ICSR reporting managed by Regulatory).