Pharmacovigilance interview preparation

1. What is pharmacovigilance?
   Pharmacovigilance (PV) is the science and activities related to identifying, evaluating, and preventing adverse effects or other drug-related problems to ensure the safe and effective use of medicines.

2. Why is pharmacovigilance important?
   Pharmacovigilance ensures patient safety by identifying and mitigating risks associated with medications. It helps maintain trust in healthcare systems by ensuring that drugs on the market are safe and effective.

3. What is the difference between adverse drug reaction (ADR) and adverse event (AE)?

   • Adverse Drug Reaction (ADR): A harmful and unintended response to a drug used at normal doses.

   • Adverse Event (AE): Any undesired medical occurrence after drug administration, regardless of whether it is caused by the drug.

4. What are the key objectives of pharmacovigilance?

   • Detecting adverse drug reactions.

   • Minimizing risks and maximizing benefits of drugs.

   • Enhancing the safe use of medicines.

   • Informing healthcare professionals and the public about potential risks.

5. What is an Individual Case Safety Report (ICSR)?
   An ICSR is a detailed report containing information about a single patient experiencing an adverse event, collected for safety monitoring and regulatory purposes.

6. What are the main steps in ICSR processing?

   • Case receipt and acknowledgment.

   • Data entry into safety databases.

   • Medical review and causality assessment.

   • Narrative writing.

   • Quality check and submission to regulatory authorities.

7. What is causality assessment in pharmacovigilance?
   Causality assessment evaluates the likelihood that a drug caused a particular adverse event. Common methods include the WHO-UMC scale and the Naranjo algorithm.

Regulations and Guidelines

8. What are the key guidelines followed in pharmacovigilance?

   • ICH-E2E: Pharmacovigilance planning.

   • ICH-E2B: Standards for electronic reporting of adverse events.

   • GVP (Good Pharmacovigilance Practices): EU guidelines for PV activities.

   • FDA Regulations: U.S. requirements for PV.

9. What is MedDRA, and why is it important in pharmacovigilance?
   MedDRA (Medical Dictionary for Regulatory Activities) is a standardized medical terminology used globally for regulatory purposes. It ensures uniform reporting and coding of adverse events.

10. What is EudraVigilance?
    EudraVigilance is the European Union’s centralized system for managing and analyzing information on suspected adverse reactions to medicines.

11. What is the difference between serious and non-serious adverse events?

    • Serious Adverse Event (SAE): Results in death, hospitalization, disability, or is life-threatening.

    • Non-Serious Adverse Event: Does not meet the criteria for an SAE but still requires monitoring.

12. What is expedited reporting?
    Expedited reporting involves submitting a report on a serious adverse reaction to regulatory authorities within a specified time frame (usually 15 calendar days).

13. What is a Periodic Safety Update Report (PSUR)?
    PSUR is a pharmacovigilance document summarizing the risk-benefit profile of a drug over a specific period, submitted periodically to regulatory authorities.

14. What is a signal in pharmacovigilance?
    A signal refers to information suggesting a new, causal association between a drug and an adverse event, requiring further investigation.

15. What is the role of a drug safety associate?

    • Collecting and reviewing adverse event data.

    • Preparing case narratives.

    • Ensuring timely and accurate submission of ICSRs.

    • Assisting in signal detection and risk assessment.

16. What skills are essential for a pharmacovigilance professional?

    • Strong knowledge of medical terminology.

    • Attention to detail for case processing.

    • Familiarity with safety databases like Argus or ARISg.

    • Good communication and teamwork skills.

17. What are some commonly used pharmacovigilance tools?

    • Argus Safety: A widely used drug safety database.

    • ARISg: Software for global safety and regulatory compliance.

    • VigiBase: WHO’s global database for adverse drug reaction reports.

18. What is the importance of coding in pharmacovigilance?
    Coding standardizes medical terms and ensures consistency in reporting. MedDRA is commonly used for coding adverse events.

19. What is signal detection, and how is it performed?
    Signal detection involves identifying patterns or trends in adverse event data that indicate a potential safety concern. It is performed using statistical methods, manual review, and data mining techniques.

20. What is the difference between active and passive surveillance in pharmacovigilance?

    • Active Surveillance: Proactively collecting data through registries or studies.

    • Passive Surveillance: Monitoring spontaneous reports of adverse events.