Introduction: Pharmacovigilance MCQs With Answer are essential for B. Pharm students to master drug safety, adverse drug reaction (ADR) identification, and signal detection. This focused set covers core topics: spontaneous reporting, causality assessment (WHO‑UMC, Naranjo), seriousness vs. severity, MedDRA coding, signal detection methods (PRR, ROR, IC), pharmacovigilance systems (WHO‑UMC, national PV centres), post‑marketing surveillance, risk management plans, and PV for biologics and vaccines. Practicing these MCQs strengthens clinical reasoning, regulatory awareness, and skills in Individual Case Safety Reports (ICSRs), benefit‑risk assessment, and risk minimization. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary objective of pharmacovigilance?
- To develop new drugs
- To monitor, detect and prevent adverse drug reactions
- To promote drug sales
- To perform routine laboratory testing
Correct Answer: To monitor, detect and prevent adverse drug reactions
Q2. Which of the following best describes an adverse drug reaction (ADR)?
- An expected therapeutic effect of a drug
- An unintended and harmful response to a drug at normal doses
- A medication error discovered after drug discontinuation
- A predictable drug interaction that enhances efficacy
Correct Answer: An unintended and harmful response to a drug at normal doses
Q3. Which classification divides ADRs into Type A and Type B?
- Severity classification
- Predictability and mechanism classification
- Regulatory reporting classification
- Pharmacokinetic classification
Correct Answer: Predictability and mechanism classification
Q4. Which causality assessment method gives categories like certain, probable, possible, unlikely?
- Naranjo algorithm
- WHO‑UMC system
- PRR analysis
- Bayesian data mining
Correct Answer: WHO‑UMC system
Q5. The Naranjo scale is primarily used to:
- Code adverse events using MedDRA
- Quantify causality between drug and event using a questionnaire
- Detect statistical signals in large databases
- Determine drug bioavailability
Correct Answer: Quantify causality between drug and event using a questionnaire
Q6. Which terminology is commonly used worldwide for standardized adverse event coding?
- SNOMED CT
- MedDRA
- ICD‑10
- LOINC
Correct Answer: MedDRA
Q7. What does an Individual Case Safety Report (ICSR) contain?
- Only laboratory values
- Aggregated epidemiological data
- Detailed information about a single suspected adverse reaction case
- Marketing strategies for a drug
Correct Answer: Detailed information about a single suspected adverse reaction case
Q8. Which signal detection measure is based on observed-to-expected ratios and is commonly used in spontaneous reporting databases?
- Kaplan‑Meier estimator
- Proportional Reporting Ratio (PRR)
- ANOVA
- Chi‑square test for trends
Correct Answer: Proportional Reporting Ratio (PRR)
Q9. In clinical trials, what is a SUSAR?
- Standardized use study adverse reaction
- Suspected unexpected serious adverse reaction
- Single‑use sterile antibiotic regimen
- Safety update summary annual report
Correct Answer: Suspected unexpected serious adverse reaction
Q10. Which regulatory document summarizes benefit‑risk and periodic safety data for marketed products?
- Investigator’s brochure
- Periodic Benefit‑Risk Evaluation Report (PBRER) / PSUR
- Clinical trial protocol
- Marketing authorization application only
Correct Answer: Periodic Benefit‑Risk Evaluation Report (PBRER) / PSUR
Q11. Which agency operates the global database VigiBase for adverse event reports?
- US FDA
- European Medicines Agency (EMA)
- WHO Uppsala Monitoring Centre (WHO‑UMC)
- Indian CDSCO
Correct Answer: WHO Uppsala Monitoring Centre (WHO‑UMC)
Q12. What is a ‘serious’ adverse event in pharmacovigilance terms?
- Any side effect that reduces patient comfort
- An event that results in death, life‑threatening condition, hospitalization, disability or congenital anomaly
- A mild transient headache
- An expected minor laboratory abnormality
Correct Answer: An event that results in death, life‑threatening condition, hospitalization, disability or congenital anomaly
Q13. Which of the following best describes ‘signal’ in pharmacovigilance?
- A confirmed causal relationship between drug and effect
- Information suggesting a new potentially causal association or new aspect of a known association between a drug and an event that warrants further investigation
- A regulatory decision to withdraw a drug
- An advertisement claiming drug safety
Correct Answer: Information suggesting a new potentially causal association or new aspect of a known association between a drug and an event that warrants further investigation
Q14. Which method is a Bayesian disproportionality measure used in signal detection?
- Reporting Odds Ratio (ROR)
- Information Component (IC)
- Fisher’s exact test
- Kaplan‑Meier curve
Correct Answer: Information Component (IC)
Q15. Which of the following is a common source of pharmacovigilance data?
- Spontaneous reporting systems
- Only randomized controlled trials
- Pharmacy billing records without clinical details
- Advertising brochures
Correct Answer: Spontaneous reporting systems
Q16. What is the role of MedWatch in the US pharmacovigilance system?
- It is a clinical trial registry
- A voluntary reporting program for adverse events to the FDA
- A manufacturing quality control protocol
- An international coding dictionary
Correct Answer: A voluntary reporting program for adverse events to the FDA
Q17. Which term describes whether an adverse reaction was foreseeable from existing product information?
- Seriousness
- Expectedness
- Preventability
- Severity
Correct Answer: Expectedness
Q18. Which risk‑minimization tool is used to restrict use or provide special monitoring for high‑risk medicines?
- Routine labeling only
- Risk Evaluation and Mitigation Strategy (REMS) or similar plans
- Generic substitution
- Standard patient leaflet without restrictions
Correct Answer: Risk Evaluation and Mitigation Strategy (REMS) or similar plans
Q19. Which PV activity involves actively following a cohort of patients exposed to a drug to collect safety data?
- Spontaneous reporting
- Cohort event monitoring
- Case‑control study only
- Randomized controlled trial safety analysis
Correct Answer: Cohort event monitoring
Q20. What is a major limitation of spontaneous reporting systems?
- They provide exact incidence rates
- Under‑reporting and reporting bias
- They always establish causality
- They are only used for vaccines
Correct Answer: Under‑reporting and reporting bias
Q21. Which parameter compares the proportion of a specific event for a drug with the same event for all other drugs in the database?
- PRR
- Bioavailability
- Half‑life
- Minimum inhibitory concentration
Correct Answer: PRR
Q22. Which document provides investigators with all relevant preclinical and clinical safety data during drug development?
- Investigator’s Brochure (IB)
- Summary of Product Characteristics (SmPC)
- Patient information leaflet
- Annual financial report
Correct Answer: Investigator’s Brochure (IB)
Q23. For suspected unexpected serious adverse reactions in clinical trials, what is the usual expedited reporting timeline for fatal or life‑threatening cases to regulatory authorities?
- 7 calendar days (initial), then 8 days for follow‑up
- 30 days
- 1 year
- No expedited reporting needed
Correct Answer: 7 calendar days (initial), then 8 days for follow‑up
Q24. Which concept refers to the assessment of whether an ADR could have been avoided?
- Seriousness assessment
- Preventability assessment
- Signal detection
- MedDRA coding
Correct Answer: Preventability assessment
Q25. Which database is primarily used by the European Medicines Agency to manage adverse event reports?
- VigiBase
- EudraVigilance
- FAERS
- PubMed
Correct Answer: EudraVigilance
Q26. What is the first step after receiving an individual adverse event report at a marketing authorisation holder?
- Immediate market withdrawal
- Data entry, triage and medical assessment of the ICSR
- Publish in a journal
- Ignore if non‑serious
Correct Answer: Data entry, triage and medical assessment of the ICSR
Q27. Which term describes adverse events related to biological products due to immunogenicity?
- Type A predictable reactions
- Immune‑mediated adverse reactions
- Pharmacokinetic variations
- Drug interactions only
Correct Answer: Immune‑mediated adverse reactions
Q28. What is the role of a Data Safety Monitoring Board (DSMB) in clinical trials?
- To market the investigational drug
- To independently review accumulating safety data and recommend continuation, modification, or termination
- To recruit patients for the trial
- To code adverse events using MedDRA
Correct Answer: To independently review accumulating safety data and recommend continuation, modification, or termination
Q29. Which activity helps reduce duplicate reporting in large safety databases?
- Ignoring older reports
- Use of de‑duplication algorithms and case linking
- Manual deletion of all similar cases
- Removing reports from certain countries
Correct Answer: Use of de‑duplication algorithms and case linking
Q30. Which element is essential in a well‑written case narrative for an ICSR?
- Detailed chronological description of events and relevant medical history
- Only the reporter’s opinion without dates
- Marketing claims about the drug
- Unverified internet comments
Correct Answer: Detailed chronological description of events and relevant medical history
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com