Setting up drug safety departments in pharmaceutical industries MCQs With Answer

Introduction

Setting up drug safety departments in pharmaceutical industries involves establishing a robust pharmacovigilance (PV) system to detect, assess, report, and prevent adverse drug reactions (ADRs). B. Pharm students must learn organizational models, PV SOPs, Individual Case Safety Report (ICSR) processing, MedDRA coding, safety databases (e.g., Argus, ARISg), signal detection, causality assessment (WHO‑UMC, Naranjo), periodic reports (PSUR/PBRER), Risk Management Plans (RMPs), regulatory timelines, and quality systems. Clear roles, training, data privacy (GDPR), and PV agreements with CROs ensure regulatory compliance and patient safety. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary objective of a drug safety (pharmacovigilance) department in a pharmaceutical company?

• Developing new marketing strategies for products
• Monitoring, collecting, evaluating, and preventing adverse drug reactions
• Managing manufacturing batch release testing
• Designing product packaging and labeling

Correct Answer: Monitoring, collecting, evaluating, and preventing adverse drug reactions

Q2. Which document provides a company‑level description of its pharmacovigilance system and is required by many regulators?

• Clinical Study Report (CSR)
• Pharmacovigilance System Master File (PSMF)
• Certificate of Analysis (CoA)
• Marketing Authorization Dossier Module 2

Correct Answer: Pharmacovigilance System Master File (PSMF)

Q3. Which coding dictionary is standard for coding adverse event terms in pharmacovigilance?

• WHO‑ART
• MedDRA
• ICD‑10
• SNOMED CT

Correct Answer: MedDRA

Q4. Which of the following best describes an Individual Case Safety Report (ICSR)?

• A lab batch record for drug release
• A clinical trial protocol amendment
• A structured report documenting a single patient adverse event associated with a suspect drug
• An investor report on product sales

Correct Answer: A structured report documenting a single patient adverse event associated with a suspect drug

Q5. Which guideline deals primarily with electronic transmission of ICSRs between stakeholders?

• ICH E2C
• ICH E2B
• ICH Q9
• FDA 21 CFR Part 11

Correct Answer: ICH E2B

Q6. Which of the following is a common pharmacovigilance database used for case management?

• Argus
• Oracle Clinical
• JMP
• Benchling

Correct Answer: Argus

Q7. In clinical trials, what is the expedited reporting timeline for a fatal or life‑threatening SUSAR to regulatory authorities for initial notification?

• 30 calendar days
• 15 calendar days
• 7 calendar days
• 90 calendar days

Correct Answer: 7 calendar days

Q8. Which causality assessment method is a structured questionnaire commonly used in PV?

• WHO‑UMC method
• Naranjo algorithm
• Bradford Hill criteria
• Kaplan‑Meier estimation

Correct Answer: Naranjo algorithm

Q9. Which activity is NOT typically part of case processing SOPs in a drug safety department?

• Intake and triage of reports
• MedDRA coding and data entry
• Aggregate CSR statistical analysis for efficacy
• Causality assessment and regulatory reporting

Correct Answer: Aggregate CSR statistical analysis for efficacy

Q10. What is the main purpose of a Risk Management Plan (RMP) for a medicinal product?

• To outline manufacturing QC specifications
• To define identified and potential risks and planned risk minimization activities
• To set pricing and reimbursement strategy
• To describe marketing and promotional activities

Correct Answer: To define identified and potential risks and planned risk minimization activities

Q11. Which term refers to an adverse event that is life‑threatening, requires hospitalization, causes disability, or results in death?

• Serious adverse event (SAE)
• Minor adverse event
• Expected adverse reaction
• Non‑serious quality issue

Correct Answer: Serious adverse event (SAE)

Q12. Which periodic safety document focuses on cumulative benefit‑risk evaluation and has largely superseded the PSUR?

• Clinical Study Report (CSR)
• Periodic Benefit‑Risk Evaluation Report (PBRER)
• Development Safety Update Report (DSUR)
• Marketing Authorization Renewal Form

Correct Answer: Periodic Benefit‑Risk Evaluation Report (PBRER)

Q13. What is a key early step in signal management after initial detection?

• Immediate market withdrawal
• Validation and case aggregation to confirm the signal
• Publishing a press release
• Filing a patent amendment

Correct Answer: Validation and case aggregation to confirm the signal

Q14. Which of the following best distinguishes seriousness from severity of an adverse event?

• Seriousness is based on regulatory criteria; severity describes intensity
• Severity is regulatory; seriousness is patient‑reported
• They are synonymous and interchangeable
• Severity determines causality; seriousness determines coding

Correct Answer: Seriousness is based on regulatory criteria; severity describes intensity

Q15. What minimum elements are generally required to constitute a valid ICSR?

• Marketing authorization holder name and batch number only
• Identifiable patient, identifiable reporter, suspect product, and described adverse event
• Clinical trial protocol and informed consent form
• Only the adverse event term without any reporter details

Correct Answer: Identifiable patient, identifiable reporter, suspect product, and described adverse event

Q16. Which international body provides commonly used case reporting forms and guidance (CIOMS) for spontaneous reporting?

• World Trade Organization (WTO)
• Council for International Organizations of Medical Sciences (CIOMS)
• International Monetary Fund (IMF)
• ISO (International Organization for Standardization)

Correct Answer: Council for International Organizations of Medical Sciences (CIOMS)

Q17. What is a typical KPI for monitoring pharmacovigilance performance in a company?

• Number of marketing campaigns per product
• Percentage of serious ICSRs reported within regulatory timelines
• Gross profit margin per product
• Number of manufacturing deviations

Correct Answer: Percentage of serious ICSRs reported within regulatory timelines

Q18. Which of the following is an example of disproportionality analysis used in signal detection?

• Regression discontinuity
• Proportional Reporting Ratio (PRR)
• ANOVA
• Fisher exact test for batch QC

Correct Answer: Proportional Reporting Ratio (PRR)

Q19. Which regulatory requirement directly impacts patient data handling and privacy in pharmacovigilance within the EU?

• ICH E2A
• GDPR (General Data Protection Regulation)
• USP pharmacopoeia
• ICH Q7

Correct Answer: GDPR (General Data Protection Regulation)

Q20. Who typically performs the medical review and clinical assessment of case narratives in a drug safety department?

• Quality assurance auditor with no medical background
• Pharmacovigilance safety physician or medically qualified assessor
• Graphic designer
• Supply chain manager

Correct Answer: Pharmacovigilance safety physician or medically qualified assessor

Q21. What is the highest level in the MedDRA hierarchical structure among the options below?

• Preferred Term (PT)
• System Organ Class (SOC)
• Lowest Level Term (LLT)
• High Level Group Term (HLGT)

Correct Answer: System Organ Class (SOC)

Q22. Which task is essential when contracting pharmacovigilance activities to a CRO?

• Ignoring PV responsibilities since CRO handles everything
• Creating a clear PV/Service Level Agreement outlining roles, responsibilities and reporting timelines
• Outsourcing without any audits or oversight
• Sharing marketing plans instead of PV requirements

Correct Answer: Creating a clear PV/Service Level Agreement outlining roles, responsibilities and reporting timelines

Q23. Which of the following best describes the content of a Periodic Benefit‑Risk Evaluation Report (PBRER)?

• Only sales data for the product
• Cumulative safety information and a benefit‑risk assessment over a reporting period
• Raw clinical trial source documents
• Manufacturing batch release test results

Correct Answer: Cumulative safety information and a benefit‑risk assessment over a reporting period

Q24. Which regulation/guidance is mainly referenced for ICSR timelines for marketed products in many regions (e.g., 15 calendar days for serious unexpected ADRs)?

• ICH E2A/CIOMS guidance and local regulatory rules
• ICH Q8
• USP standards
• ICH M4

Correct Answer: ICH E2A/CIOMS guidance and local regulatory rules

Q25. Which step sequence correctly describes standard case processing in many PV departments?

• Medical review → Intake → Coding → Reporting
• Intake → Triage → Data entry and coding → Medical assessment → Reporting
• Reporting → Intake → Triage → Coding
• Coding → Intake → Filing → Reporting

Correct Answer: Intake → Triage → Data entry and coding → Medical assessment → Reporting

Q26. Which analysis is commonly used to identify disproportionate reporting of an event for a drug compared to others in a database?

• Root cause analysis for manufacturing deviations
• Disproportionality analysis (e.g., PRR, ROR)
• Cost‑benefit analysis
• Stability testing

Correct Answer: Disproportionality analysis (e.g., PRR, ROR)

Q27. Which element is NOT usually included in PV SOPs for literature screening?

• Search strategies and databases to screen
• Case identification and capture criteria
• Procedures for handling duplicates and follow‑up
• Detailed clinical trial randomization code

Correct Answer: Detailed clinical trial randomization code

Q28. What is a common cause of under‑reporting of ADRs by healthcare professionals?

• High awareness and incentives to report
• Lack of awareness or perceived complexity of reporting processes
• Strict regulatory monitoring that forces reporting
• Overabundance of pharmacovigilance staff

Correct Answer: Lack of awareness or perceived complexity of reporting processes

Q29. What feature is essential for a validated PV database to ensure compliance?

• Absence of audit trail to simplify records
• Data integrity, audit trail, role‑based access controls and electronic validation
• Open public write access for all users
• No backup or disaster recovery plan

Correct Answer: Data integrity, audit trail, role‑based access controls and electronic validation

Q30. Which report is specific for safety reporting during clinical development (ongoing trials) and summarizes safety from development programs?

• Periodic Safety Update Report (PSUR) for marketed products
• Development Safety Update Report (DSUR)
• Pharmacopoeial monograph
• Certificate of Pharmaceutical Product (CPP)

Correct Answer: Development Safety Update Report (DSUR)

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