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1. Pharmacovigilance Interview Questions

2. These questions are for those who are looking to get a job in pharmacovigilance and want to get an idea of pharmacovigilance, however these are just some common questions that can be asked. In order to obtain more knowledge on pharmacovigilance you must go for a course. Pharmamentors provides pharmacovigilance training that can help you in acquiring knowledge and skills of pharmacovigilance and clear your interview. Some common pharmacovigilance questions are as follows:

3. What is the difference between adverse drug reaction and adverse drug event.? What is the difference between adverse drug reaction and adverse drug event. Adverse drug reactions are events where harm is directly caused by drugs under appropriate use (i.e at normal dose). An adverse drug event is harm caused by appropriate or inappropriate use of drugs.

4. What do you mean by SUSAR? Any unfavorable occurrence on a trial participant that is judged to have a major impact on their health, was not anticipated and could potentially due to intervention under investigation is called SUSAR.

5. What is ICSR? Individual case safety reports contain information on adverse events or suspectedadverse reactions associated with medicinal products. The information from an ICSRreport is stored in a safety database.

6. What are the validity criterias for ICSR? There are 4 validity criterias, they are: 1) An identifiable reporter 2) An identifiable patient 3)Suspected medicinal product 4) An adverse drug reaction

7. What are medwatch forms and CIOMS forms? A medwatch form is used to report adverse or sentinel events to medwatch.CIOMS form provides a standardized format for the reporting of adverse drug reactionsto any particular medicinal product.

8. What is causality assessment? Causality assessment essentially means finding a causal association or relationship between a drug and drug reaction.

9. What is a safety database? Safety databases collect information to accurately assess and characterize the risk of a new drug.

10. What do you mean by ICH-GCP guidelines? The International Council for Harmonisation of Technical Requirements forPharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) is aninternationally agreed standard that ensures ethical and scientific quality in designing,recording and reporting trials that involve human subjects.

11. What is a serious adverse event? A serious adverse event (SAE) in human trials is defined as any untoward medicaloccurrence that at any dose results in death, are life threatening, require inpatient orprolonged hospitalization, results in persistent disability/ incapacity or result incongenital anomaly/birth defect.

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