What is Pharmacovigilance?
Pharmacovigilance is the process of
(a) Monitoring the safety of medicines as used in everyday practice or in clinical programs in order to identify previously unrecognized adverse effects, adverse events or changes in the patterns of adverse effects
(b) Assessing the risks and benefits of medicines in order to determine what action, if any, is necessary to improve their safe use
(c) Providing information to users to optimize safe and effective use of medicines
(d) Monitoring the impact of any action taken
What is Adverse Event Case Reporting?
An Adverse Event is an untoward medical occurrence in a patient or clinical investigation subject, administered a pharmaceutical product or device, or in an operator of a device, and that does not necessarily have a causal relationship with the use of the product or device.
Adverse event reporting is done across the life-span of a pharmaceutical product or device – both before and after market approval – to continuously evaluate and analyze its safety profile. Adverse Event data is assessed for classification, reportability, and safety signals. The case reporting process includes entering the data into a safety database; composing a narrative of the event; medically coding the Adverse Event terms; putting the case report through medical and regulatory review; and reporting the case per country or community regulations, to national competent authorities, IRBs/ECs, investigators, and business partners, as applicable.