Top Pharmacovigilance Interview Questions with Detailed Answers
🧠 Practice Before Interview
🚀 Take PV QuizThis guide contains the most important pharmacovigilance interview questions with detailed answers for freshers.
📚 Pharmacovigilance Interview Questions
-
1. What is Pharmacovigilance?
Pharmacovigilance is the science and activity related to detecting, assessing, understanding, and preventing adverse effects of drugs. Its main goal is to ensure patient safety and improve safe drug usage. -
2. What is an Adverse Event (AE)?
An Adverse Event (AE) is any unwanted medical occurrence after taking a drug. It may or may not be related to the drug. -
3. What is an Adverse Drug Reaction (ADR)?
An ADR is a harmful and unintended reaction caused by a drug at normal doses. It has a direct relationship with the drug. -
4. Difference between AE and ADR?
AE = any unwanted event (drug related or not) ADR = directly caused by drug 👉 All ADRs are AEs, but not all AEs are ADRs. -
5. What is ICSR?
ICSR (Individual Case Safety Report) is a structured report containing: Patient + Drug + Adverse Event + Reporter details. It is the core unit of pharmacovigilance. -
6. What is a Serious Adverse Event (SAE)?
A Serious Adverse Event includes: ✔ Death ✔ Hospitalization ✔ Life-threatening condition ✔ Disability ✔ Congenital anomaly -
7. What is causality assessment?
Causality assessment determines whether a drug caused an adverse event using: ✔ Time relationship ✔ Dechallenge/Rechallenge ✔ Alternative causes -
8. What is MedDRA?
MedDRA is a standardized medical dictionary used for coding adverse events globally. It ensures consistent data reporting. -
9. What is signal detection?
Signal detection is identifying new or unknown risks associated with a drug from collected data. -
10. What is spontaneous reporting?
Spontaneous reporting is voluntary reporting of adverse events by doctors or patients without any study. -
11. What is duplicate case?
A duplicate case occurs when the same case is reported multiple times. It must be identified and merged. -
12. What is follow-up?
Follow-up is collecting missing or additional information to complete a case. -
13. What is expectedness?
Expectedness means whether the adverse event is already listed in the product label. -
14. Difference between seriousness and severity?
Seriousness = regulatory outcome (death, hospitalization) Severity = intensity (mild, moderate, severe) -
15. What is a narrative?
A narrative is a chronological summary of the case describing patient history and events. -
16. What is coding?
Coding means assigning MedDRA terms to adverse events. -
17. What is case intake?
Case intake is the process of receiving and registering a new case. -
18. What is triage?
Triage means prioritizing cases based on seriousness and timelines. -
19. What are minimum criteria for valid case?
✔ Identifiable patient ✔ Identifiable reporter ✔ Suspect drug ✔ Adverse event -
20. What is case processing?
Case processing includes: ✔ Data entry ✔ Coding ✔ Medical review ✔ Submission
-
21. What is QC (Quality Check)?
Quality Check (QC) is the process of verifying that all case data is accurate, complete, and consistent. It ensures compliance with regulatory guidelines before submission. -
22. What is case locking?
Case locking is the final step where the case is finalized and no further changes can be made. It ensures data integrity before submission. -
23. What is E2B?
E2B is a standard electronic format used for transmitting Individual Case Safety Reports (ICSRs) to regulatory authorities. It ensures uniform data exchange globally. -
24. What is expedited reporting?
Expedited reporting refers to the fast submission of serious and unexpected adverse events within strict timelines defined by regulatory agencies. -
25. What is submission?
Submission is the process of sending finalized safety reports to regulatory authorities such as FDA, EMA, or CDSCO. -
26. What is audit trail?
An audit trail is a record that tracks all changes made in the database, including who made the change and when. It ensures transparency and traceability. -
27. What is Argus?
Argus Safety is a widely used pharmacovigilance database system for managing and reporting adverse events. -
28. What is reconciliation?
Reconciliation is the process of comparing and matching data between different sources (e.g., safety database vs clinical database) to ensure consistency. -
29. What is validation in pharmacovigilance?
Validation is checking whether the case data is correct, complete, and compliant with regulatory standards before submission. -
30. What is a safety database?
A safety database is a system used to store, manage, and process adverse event reports. Examples include Argus, ARISg, Veeva Safety. -
31. What is case workflow?
Case workflow refers to the step-by-step process of handling a case from intake to submission and closure. -
32. What is medical review?
Medical review is performed by a qualified medical professional to ensure correct clinical interpretation of the case. -
33. What is literature case?
A literature case is an adverse event identified from published medical journals or scientific articles. -
34. What is clinical trial case?
A clinical trial case is an adverse event reported during clinical studies before the drug is approved. -
35. What is post-marketing surveillance?
Post-marketing surveillance is the monitoring of drug safety after it is launched in the market. -
36. What is a blinded study?
A blinded study is one where treatment details are hidden from participants or investigators to avoid bias. -
37. What is unblinding?
Unblinding is the process of revealing the treatment details when required for safety evaluation. -
38. What is case priority?
Case priority means handling serious cases first due to strict regulatory timelines. -
39. What is ICH?
ICH (International Council for Harmonisation) provides global guidelines for drug safety and pharmacovigilance. -
40. What is GVP?
GVP (Good Pharmacovigilance Practices) are guidelines that ensure proper monitoring and reporting of drug safety.
-
41. What is CDSCO?
CDSCO (Central Drugs Standard Control Organization) is the regulatory authority of India responsible for drug approval, safety monitoring, and clinical trial regulation. -
42. What is US FDA?
US FDA (Food and Drug Administration) is the regulatory body of the United States that ensures the safety, efficacy, and quality of drugs. -
43. What is EMA?
EMA (European Medicines Agency) is responsible for evaluating and monitoring medicines in Europe. -
44. What is PSUR?
PSUR (Periodic Safety Update Report) is a report submitted at regular intervals to evaluate the risk-benefit profile of a drug after approval. -
45. What is DSUR?
DSUR (Development Safety Update Report) is used during clinical trials to monitor the safety of investigational drugs. -
46. What is RMP?
RMP (Risk Management Plan) outlines how the risks of a drug will be identified, monitored, and minimized. -
47. What is SOP?
SOP (Standard Operating Procedure) is a detailed document describing step-by-step processes to ensure consistency and compliance. -
48. What is compliance?
Compliance means following all regulatory guidelines, SOPs, and company policies accurately. -
49. What is benefit-risk analysis?
Benefit-risk analysis compares the therapeutic benefits of a drug with its potential risks to ensure safe usage. -
50. What is GDPR?
GDPR (General Data Protection Regulation) is a law that ensures protection of personal and patient data. -
51. What is an audit?
An audit is an internal review conducted to ensure that processes follow SOPs and regulatory standards. -
52. What is an inspection?
An inspection is conducted by regulatory authorities to verify compliance with regulations. -
53. What is CAPA?
CAPA (Corrective and Preventive Action) is a process used to identify, correct, and prevent errors in pharmacovigilance activities. -
54. What is a PV system?
A Pharmacovigilance system is a structured system used to monitor, collect, and evaluate drug safety data. -
55. What is a safety signal?
A safety signal is information suggesting a new or unknown risk associated with a drug. -
56. What is signal validation?
Signal validation is the process of confirming whether a detected signal is valid and relevant. -
57. What is signal evaluation?
Signal evaluation involves analyzing validated signals to determine their clinical significance and impact. -
58. What is risk minimization?
Risk minimization includes actions taken to reduce the risks associated with a drug (e.g., label changes, warnings). -
59. What is data privacy?
Data privacy refers to protecting personal and patient information from unauthorized access. -
60. What is anonymization?
Anonymization is the process of removing personal identifiers from data to protect patient identity.
-
61. What is follow-up attempt?
A follow-up attempt is the process of contacting the reporter multiple times to collect missing or additional information required for case completion. -
62. What is case completeness?
Case completeness means ensuring that all mandatory fields and relevant information in a case are properly filled. -
63. What is coding accuracy?
Coding accuracy refers to selecting the correct MedDRA term for an adverse event to maintain data quality. -
64. Why choose pharmacovigilance as a career?
Pharmacovigilance offers a career focused on patient safety, with strong growth opportunities, global exposure, and involvement in drug safety. -
65. What are your strengths?
Common strengths include: ✔ Attention to detail ✔ Analytical thinking ✔ Accuracy and consistency -
66. What are your weaknesses?
Mention a realistic weakness and show improvement, e.g., "I focus too much on details, but I am improving my time management." -
67. What is your career goal?
Your goal should reflect growth in pharmacovigilance, such as becoming a drug safety expert or moving into signal detection or medical review. -
68. How do you handle pressure?
Handling pressure involves prioritizing tasks, managing time effectively, and staying calm during deadlines. -
69. What is teamwork?
Teamwork is the ability to work collaboratively with others to achieve common goals efficiently. -
70. What is time management?
Time management means completing tasks within deadlines by planning, prioritizing, and organizing work. -
71. What is communication skill?
Communication skill is the ability to clearly explain information in a simple and effective manner. -
72. What is problem-solving?
Problem-solving is the ability to analyze issues and find effective solutions quickly. -
73. How do you learn new things?
Learning involves practice, continuous reading, training, and hands-on experience. -
74. What are MedDRA levels?
MedDRA hierarchy includes: ✔ LLT (Lowest Level Term) ✔ PT (Preferred Term) ✔ HLT ✔ HLGT ✔ SOC (System Organ Class) -
75. What is case lifecycle?
Case lifecycle includes all stages: Case intake → Processing → Review → Submission → Closure -
76. What is seriousness criteria?
Seriousness criteria include outcomes like: ✔ Death ✔ Hospitalization ✔ Life-threatening condition ✔ Disability -
77. What tools are used in pharmacovigilance?
Common tools include: ✔ Argus Safety ✔ Veeva Safety ✔ ARISg -
78. What is the future of pharmacovigilance?
The future includes automation, artificial intelligence (AI), and advanced data analytics to improve efficiency. -
79. What is AI in pharmacovigilance?
AI helps in automating case processing, signal detection, and data analysis, reducing manual effort. -
80. What are data entry errors?
Data entry errors are mistakes made while entering case data, which can affect accuracy and compliance.
-
61. What is follow-up attempt?
A follow-up attempt is the process of contacting the reporter multiple times to collect missing or additional information required for case completion. -
62. What is case completeness?
Case completeness means ensuring that all mandatory fields and relevant information in a case are properly filled. -
63. What is coding accuracy?
Coding accuracy refers to selecting the correct MedDRA term for an adverse event to maintain data quality. -
64. Why choose pharmacovigilance as a career?
Pharmacovigilance offers a career focused on patient safety, with strong growth opportunities, global exposure, and involvement in drug safety. -
65. What are your strengths?
Common strengths include: ✔ Attention to detail ✔ Analytical thinking ✔ Accuracy and consistency -
66. What are your weaknesses?
Mention a realistic weakness and show improvement, e.g., "I focus too much on details, but I am improving my time management." -
67. What is your career goal?
Your goal should reflect growth in pharmacovigilance, such as becoming a drug safety expert or moving into signal detection or medical review. -
68. How do you handle pressure?
Handling pressure involves prioritizing tasks, managing time effectively, and staying calm during deadlines. -
69. What is teamwork?
Teamwork is the ability to work collaboratively with others to achieve common goals efficiently. -
70. What is time management?
Time management means completing tasks within deadlines by planning, prioritizing, and organizing work. -
71. What is communication skill?
Communication skill is the ability to clearly explain information in a simple and effective manner. -
72. What is problem-solving?
Problem-solving is the ability to analyze issues and find effective solutions quickly. -
73. How do you learn new things?
Learning involves practice, continuous reading, training, and hands-on experience. -
74. What are MedDRA levels?
MedDRA hierarchy includes: ✔ LLT (Lowest Level Term) ✔ PT (Preferred Term) ✔ HLT ✔ HLGT ✔ SOC (System Organ Class) -
75. What is case lifecycle?
Case lifecycle includes all stages: Case intake → Processing → Review → Submission → Closure -
76. What is seriousness criteria?
Seriousness criteria include outcomes like: ✔ Death ✔ Hospitalization ✔ Life-threatening condition ✔ Disability -
77. What tools are used in pharmacovigilance?
Common tools include: ✔ Argus Safety ✔ Veeva Safety ✔ ARISg -
78. What is the future of pharmacovigilance?
The future includes automation, artificial intelligence (AI), and advanced data analytics to improve efficiency. -
79. What is AI in pharmacovigilance?
AI helps in automating case processing, signal detection, and data analysis, reducing manual effort. -
80. What are data entry errors?
Data entry errors are mistakes made while entering case data, which can affect accuracy and compliance.
-
81. What are coding errors?
Coding errors occur when the wrong MedDRA term is selected for an adverse event. This can impact data accuracy and signal detection. -
82. How do you handle duplicate cases?
Duplicate cases are handled by identifying similarities (patient, event, drug) and then merging them into a single valid case. -
83. What is case prioritization?
Case prioritization means handling serious and time-sensitive cases first based on regulatory timelines. -
84. What is a common mistake in pharmacovigilance?
Common mistakes include: ✔ Incorrect data entry ✔ Wrong coding ✔ Missing information -
85. How do you ensure data accuracy?
Data accuracy is ensured by: ✔ Double-checking entries ✔ Performing QC ✔ Following SOPs -
86. What is an interview tip for pharmacovigilance?
Always explain concepts clearly, use simple language, and focus on strong basics. -
87. How can you improve communication skills?
Improve by practicing regularly, speaking clearly, and using simple and structured sentences. -
88. How should you prepare for interviews?
Preparation includes: ✔ Revising basic concepts ✔ Practicing questions ✔ Mock interviews -
89. What is the importance of mock interviews?
Mock interviews help improve confidence, communication, and answer clarity. -
90. How to build confidence?
Confidence comes from practice, preparation, and positive mindset. -
91. What is a resume tip?
Highlight: ✔ Relevant skills ✔ Internships/training ✔ Key pharmacovigilance knowledge -
92. How to handle HR round?
Be honest, confident, and professional. Focus on personality and attitude. -
93. How to clear technical round?
Have strong knowledge of basic pharmacovigilance concepts and explain answers clearly. -
94. How to perform in final round?
Show confidence, clarity, and interest in the role and company. -
95. What to say about salary expectation?
Be realistic and flexible based on your experience and market standards. -
96. How to answer notice period question?
Clearly mention your availability or current notice period without confusion. -
97. What is flexibility in job?
Flexibility means willingness to learn new tasks, adapt to changes, and work in different roles. -
98. What is career growth in pharmacovigilance?
Career growth includes moving from case processing → medical review → signal detection → management roles. -
99. Why do you want to join this company?
Show that you have researched the company and are interested in its work culture, growth, and opportunities. -
100. Final interview tip?
Always stay confident, speak in simple English, and focus on clarity over complexity. Strong fundamentals matter the most.
.png)
