MRCT – A process to detect, review, and make decisions about drug safety to protect patients.
https://mrctcenter.org/glossaryterm/pharmacovigilance/
CDISC-Gloss – Process and science of monitoring the safety of medicines and taking action to reduce their risks and increase their benefits. NOTE: Pharmacovigilance is a key public health function that comprises: collecting and managing data on the safety of medicines; looking at the data to detect ‘signals’ (any new or changing safety issue); evaluating the data and making decisions with regard to safety issues; acting to protect public health (including regulatory action);communicating with stakeholders; auditing of both the outcomes of action taken and the key processes involved. [After IDMP] See also postmarketing surveillance.