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Ragupathy Renganathan
Ragupathy Renganathan
Pharma Hub

MCQ Practice

Pharmacovigilance MCQs with Answers and Explanations

Pharmacovigilance MCQs concentrate on definitions and deadlines, because those are exactly what a safety associate is held to in practice.

Use the explanations to fix the timelines in memory before the full test.

10 free questions shown · 100 in the full test

Topics covered

  • ADR types and classification
  • ICSR and E2B
  • Causality assessment scales
  • Reporting timelines
  • Aggregate safety reports

10 Pharmacovigilance MCQs with answers

  1. Q1

    Pharmacovigilance is defined as the science of:

    • ADrug manufacturing
    • BDetection, assessment, understanding and prevention of adverse effects
    • CDrug marketing
    • DDrug pricing

    Explanation: WHO definition of pharmacovigilance focuses on adverse drug reactions and drug-related problems.

  2. Q2

    ADR stands for:

    • AAdverse Drug Reaction
    • BAnnual Drug Report
    • CAuthorized Drug Registry
    • DApproved Drug Record

    Explanation: ADR = Adverse Drug Reaction — a harmful, unintended response to a medicine.

  3. Q3

    ICSR stands for:

    • AIndividual Case Safety Report
    • BInternational Clinical Safety Review
    • CInternal Compliance Safety Record
    • DIndustry Council on Safety Reporting

    Explanation: ICSR documents an adverse event report for a single patient.

  4. Q4

    Serious adverse event criteria include all EXCEPT:

    • ADeath
    • BHospitalization
    • CMild headache
    • DLife-threatening

    Explanation: SAEs include death, life-threatening, hospitalization, disability, congenital anomaly, important medical event.

  5. Q5

    PSUR stands for:

    • APeriodic Safety Update Report
    • BPatient Safety Usage Record
    • CPharmacovigilance Standard Update Review
    • DPost-Sale Use Report

    Explanation: PSUR (now PBRER under ICH E2C(R2)) is a periodic safety update report.

  6. Q6

    Causality assessment scales include:

    • AWHO-UMC, Naranjo
    • BBradford-Hill only
    • COOS scale
    • DANOVA

    Explanation: WHO-UMC and Naranjo are commonly used causality assessment tools.

  7. Q7

    MedDRA is used for:

    • AMedical terminology coding
    • BManufacturing data
    • CMarketing data
    • DMethod validation

    Explanation: MedDRA standardizes medical terms for ADR coding.

  8. Q8

    Expedited reporting of a serious unexpected ADR to authorities is within:

    • A7 calendar days for fatal/life-threatening, 15 days otherwise
    • B30 days
    • C60 days
    • D90 days

    Explanation: Fatal/life-threatening = 7 days; other serious unexpected = 15 days.

  9. Q9

    QPPV stands for:

    • AQualified Person for Pharmacovigilance
    • BQuality Process for Product Verification
    • CQuarterly Product Performance Verification
    • DQuick Pharma Practice Validation

    Explanation: QPPV is the EU-mandated responsible person for pharmacovigilance.

  10. Q10

    A signal in PV is:

    • AConfirmed ADR
    • BReported information on a possible causal relationship
    • CManufacturing alarm
    • DSales spike

    Explanation: A signal is information suggesting a new potential causal association requiring further evaluation.

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