PVC Adverse Event Reporting & Case Management 1

Question 1

Which of the following is considered a serious adverse event (SAE)?

Accepted Answer

Hospitalization due to severe allergic reaction

Answer

An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization, or causes significant disability.

Question 2

What is the minimum required information to consider a valid Individual Case Safety Report (ICSR)?

Accepted Answer

Four minimum criteria: reporter, patient, event, drug

Answer

A valid ICSR must include four elements: an identifiable reporter, an identifiable patient, a suspected adverse event, and a suspected drug.

Question 3

Which coding system is primarily used to classify adverse events in pharmacovigilance?

Accepted Answer

MedDRA

Answer

MedDRA (Medical Dictionary for Regulatory Activities) is the standard terminology used globally to code and classify adverse events.

Question 4

Who is responsible for reporting adverse events in post-marketing surveillance?

Accepted Answer

Healthcare providers, patients, and manufacturers

Answer

Healthcare professionals, patients, and the Marketing Authorization Holder (MAH) all play roles in reporting adverse events after a drug is marketed.

Question 5

What is the appropriate timeline for reporting a fatal adverse drug reaction to regulatory authorities?

Accepted Answer

7 calendar days

Answer

A fatal adverse drug reaction must be reported within 7 calendar days according to international pharmacovigilance guidelines.

(PVC) Pharmacovigilance Certification Practice Test