Pharmacovigilance Training Assessment Quiz - Nov.2025
SOP.QA.04v5 PHARMACOVIGILANCE, SOP.QA.05v5 HANDLING OF ADVERSE EVENTS, SOP.QA.06v4 HANDLING PRODUCT RELATED CUSTOMER COMPLAINTS
Name
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First Name
Last Name
Email
*
@aventalimited.com
Department
*
Please Select
Pharma BU1
Pharma BU2
Pharma BU3
Consumer
Customer Service
POS Branch
South Branch
MMD
Other
Instructions for the Quiz
Please answer all questions to the best of your ability. Each question is worth one point, this assessment has a passing grade of 7 points.
1. An adverse event is defined as any unfavourable and unintended change in the body (e.g. sign, symptom, or abnormal laboratory finding) associated with the use of a product, whether or not considered related to the use of said product.
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True
False
2. P-R-E-P is an acronym for the 4 basic reporting criteria for an adverse event. What does it stand for?
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Patient– Reporter – Event – Product
Position – Report – Event –Product
Patient – Response – Event– Product
Patient – Reporter –Evaluation – Product
3. Which of the following is NOT an example of Product Quality Complaint (PQC)?
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Change in appearance.
Misuse or abuse of product.
Broken tablets.
Contamination by foreign substances and particle.
4. Which of the following patient data must NOT be shared to ensure confidentiality and data protection?
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Patient full name
Patient initials
Age /DOB
Gender
5. Which of the following are the correct way(s) to route Adverse Event /Product Quality Complaint to the Pharmacovigilance Department:
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Fax, Email
Pharmacovigilance contact no.
Backup contact no.
Website
All of them
None of them
6. Why is Pharmacovigilance important?
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It helps in tracking patients in the event of a product recall.
It contributes to the protection of patients and public health by preventing potential harm from adverse drug reactions.
It immediately notifies patients about adverse events.
It allows customers to receive refunds due to adverse events in a timely manner.
7. Whom of the following play a role in Pharmacovigilance?
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Consumers
Patients
Healthcare professionals
All of the above.
8. After receiving an adverse event report, when should you submit it to the appropriate channel?
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Within 5 working days.
No longer than 36 hours.
No longer than 24 hours.
No longer than 48 hours.
9. Who is responsible for sharing the information of an adverse report to the supplier?
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The Aventa Sales Representative.
The Line Manager
The Divisional Head
The Pharmacists/Regulatory Personnel
10. An employee in the Customer Service Department receives a product quality complaint. Who should they pass the information to?
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The Line Manager
The Pharmacists / Regulatory Personnel
The Sales and Marketing Manager
The Medical Representative
Score
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