Pharmacovigilance Quiz

Pharmacovigilance monitors the _______ of drugs.

• A. Action

• B. Adverse Effects

• C. Dosage

• D. Expiration

As per the revised Distriphil PV SOP effective 19 January 2021, what is the timeline for reporting adverse events to the Distriphil PV Unit?

• A. 12 hours

• B. 1 Business Day

• C. 24 hours

• D. 1 week

This is defined as any communication that describes a potential defect related to the identity, strength, quality or purity of a product after it is released/distributed for use by a customer.

• A. Serious adverse events

• B. Product quality complaint

• C. Adverse Events

• D. Adverse Drug Reaction

The Distriphil Drug Safety email address is:

• A. [e-mail]

• B. [e-mail]

• C. [e-mail]

• D. [e-mail]

A serious events results in:

• A. Death

• B. Hospitalization

• C. Life-Threatening condition

• D. All of the above

The patient involved in the adverse event should be identified with:

• A. Initials or age or age group only

• B. email address

• C. Full Name

• D. Complete Address

The adverse event reports we gather involve:

• A. all brands in the market

• B.Distriphil products and partner-products only

• C. Vaccines Only

• D. All generic counterparts of our products

Who is NOT included in the Distriphil PV Unit?

• A. Medical and Regulatory Affairs Head

• B. Regulatory Affairs Manager

• C. Product Manager

• D. QMS Manager

Which of the following is NOT a necessary information when reporting an adverse event?

• A. patient information

• B. Product

• C. Reporter

• D. Proof of hospitalization of the patient

All adverse events should be reported regardless of nature, seriousness and severity.

• A. True

• B. False