Pharmacovigilance is gaining global attention as a multi- and cross-area discipline that deals with the incidence and frequency of adverse events related to pharmaceuticals and medical devices worldwide. The reporting of these events is critical to building a valid pharmacovigilance program that can effectively identify issues before they impact public health.

However, language can be a barrier in reporting. In many instances, adverse events and databases are reported in the local language. The adverse effect reports (AERs) must be translated from the local language to English, with care being taken to ensure that patient confidentiality is not breached at any point. Eventually, these reports are translated into multiple languages to meet various countries’ requirements. How prepared is your organization to address pharmacovigilance standards?