Serious Event or Serious Suspected Adverse Reaction in Pharmacovigilance Practice

An adverse event or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes :

-Death
-A life-threatening adverse event
-Inpatient hospitalization, or prolonged of existing hospitalization
-A persistent disability to conduct normal functions
-A congenital anomaly/birth defect

Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious, when based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

Author- Sirisha Boidapu, Pharmacist, PV Professional