Top Pharmacovigilance Interview Questions and Answers (Fresher to Experience)

Title: Pharmacovigilance Interview Questions and Answers

1. Define Pharmacovigilance
   Pharmacovigilance is the science of collecting, monitoring, researching, evaluating, and interpreting data from healthcare professionals and patients about the adverse effects of medicines, biological products, herbal treatments, and other medical substances. The purpose is to ensure drug safety and protect public health.

2. What Are the Minimum Criteria Required for a Valid Case?
   A valid safety case must contain:
   • An identifiable reporter
   • An identifiable patient
   • A suspect product
   • An adverse drug event

3. Define Adverse Drug Event (ADE)
   An Adverse Drug Event is any undesirable medical occurrence that happens after the administration of a pharmaceutical product, regardless of whether it is related to the drug.

4. Define Adverse Drug Reaction (ADR)
   An Adverse Drug Reaction is a harmful, unintended response to a drug that occurs at normal doses used for diagnosis, treatment, or prevention of disease. ADR implies a suspected causal relationship.

5. What Is the Difference Between ADE and ADR?
   An ADE may or may not be caused by the drug.
   An ADR requires a suspected causal link between the drug and the adverse reaction.

6. Define Volume 9A
   Volume 9A provides guidelines for pharmacovigilance requirements in the European Union. It describes roles, responsibilities, safety reporting expectations, and general PV activities for Marketing Authorization Holders and Regulatory Authorities.

Volume 9A contains four parts:
Part I – Guidelines for Marketing Authorization Holders
Part II – Guidelines for Competent Authorities and the Agency
Part III – Guidelines for electronic exchange of pharmacovigilance data
Part IV – Guidelines on pharmacovigilance communication

7. When Is a Case Considered Medically Confirmed?
   A case is medically confirmed when at least one adverse event is confirmed or reported by a qualified healthcare professional (HCP).

   
   
   

8. What Is Meant By Causality?
   Causality is the relationship between the suspect product and the adverse drug event. It determines whether the drug likely caused the event.

9. Mention Some Key Data Elements in an ICSR
   • Patient details: age, gender, race
   • Suspect drug details: name, dose, dosage form, dates, indication
   • Adverse event information and outcomes
   • Reporter details

10. What Should a Narrative Include?
    A narrative should clearly describe:
    • Patient demographics
    • Medical history
    • Suspect drug details
    • Event timeline
    • Clinical treatment and outcomes
    It must be clear, chronological, and factual.

11. Define MedDRA
    MedDRA is the Medical Dictionary for Regulatory Activities. It is a globally accepted standardized medical terminology used for coding adverse events.

12. What Is the Hierarchy in MedDRA?
    • System Organ Class (SOC)
    • High Level Group Term (HLGT)
    • High Level Term (HLT)
    • Preferred Term (PT)
    • Lower Level Term (LLT)

13. Explain E2A, E2B, and E2C Guidelines
    E2A: Provides standard terminology and guidance for expedited reporting of adverse drug reactions during clinical research.
    E2B: Defines format and data elements for electronic transmission of individual case safety reports (ICSRs).
    E2C: Provides guidelines for preparing Periodic Safety Update Reports (PSURs) for marketed products.

14. What Are Data Assessments in Pharmacovigilance?
    • Individual case assessment
    • Aggregate data interpretation
    • Signal detection
    • Risk factor and interaction evaluation
    • Trend and frequency analysis
    • Continuous safety monitoring

15. What Are the Types of Pharmacovigilance?
    Two main types:

16. Active Pharmacovigilance: Actively seeks adverse events through patient follow-up and monitoring.

17. Passive Pharmacovigilance: Relies on voluntary reporting (spontaneous reporting).

18. When Do You Consider an Event Serious?
    An event is considered serious if it involves:
    • Death
    • Life-threatening condition
    • Hospitalization or extended hospitalization
    • Disability or permanent impairment
    • Congenital anomaly
    • Medically significant condition

19. Name Regulatory Authorities in Different Countries
    USA: USFDA
    UK: MHRA
    Japan: MHLW
    India: CDSCO

20. Career Path in Pharmacovigilance
    Pharmacovigilance professionals perform drug safety data management, risk evaluation, and safety reporting. There are strong career opportunities in pharmaceutical companies, CROs, and healthcare organizations.

Common Job Roles:
• Drug Safety Associate
• Medical Reviewer
• Pharmacovigilance Officer
• Pharmacovigilance Scientist
• Risk Management Specialist
• Drug Safety Data Manager
• Consultant – Argus Safety Configuration