pharmacovigilance department each case is processed, assessed as to its relationship (causality) to the investigational product, and reported to the regulatory authorities and other stakeholders, either as an expedited report or as part of an aggregate report, based upon pharmacovigilance policies, regulations, and guidance documents.

Pharmacovigilance involves monitoring, preventing and assessing risks. Pharmacovigilance certification is a specialized certification program that provides individuals with knowledge and skills in the area of pharmacovigilance. Pharmacovigilance training brings increased employment opportunities with regulatory affairs