What does pharmacovigilance primarily involve?

Pharmacovigilance primarily involves adverse event monitoring and reporting, which is essential for ensuring the safety of drug products once they are on the market. This process encompasses the collection, analysis, and interpretation of data regarding the side effects or adverse effects that may occur after drug administration. The goal is to identify any potential safety issues and to take necessary actions to mitigate risks, which may include updating product labeling, conducting additional studies, or even removing a product from the market if necessary.

The emphasis on monitoring and reporting aligns with regulatory requirements to safeguard public health by ensuring that emerging safety information is effectively communicated and assessed. This systematic approach is critical to maintaining ongoing evaluation of drug safety over time, which stems from not just the trials conducted before approval but also from real-world usage in diverse populations after approval.