Pharmacovigilance Interview Questions -01
In this article, we are going to learn about the most frequently asked questions in Pharmacovigilance interviews and if you are interested in making a career in pharmacovigilance these questions are very important to get into the pharmacovigilance domain and this is part -1 only remaining questions are in part 2
- Define Pharmacovigilance?
Answer: According to WHO, Pharmacovigilance is defined as the Science and Activities Relating To
Detection, Assessment, Understanding & Prevention of Adverse Reactions or any other drug-related
Problems.
2. What are the criteria for a valid case?
Answer: For a valid case, there must be an identifiable reporter, an identifiable patient, a suspect drug product, and an adverse drug event.
3. What are the types of Pharmacovigilance?
Answer: There are two types of Pharmacovigilance a) Active Pharmacovigilance and b) Passive Pharmacovigilance
4. What is a side effect?
Answer: Unintended effect of a drug product occurring at normal doses due to pharmacological properties and sometimes a side effect is beneficial.
5. What is a signal in PV?
Answer: A signal is a report containing information regarding a possible causal relation between an adverse event and a drug and the relation is unknown or incompletely documented previously. and to generate a signal one report is not sufficient and it also depends on the seriousness of the event and the quality of the available information.
6. What is VigiAcess – It is an open access to the WHO database, which contains suspected adverse drug reactions.
7. What is Vigibase – WHO database of individual Case Safety report and Vigiflow is analytical tool of WHO for spontaneous reporting data entry.
8. What are Periodic safety update reports?
PSUR’S are documents which are submitted periodically, and it contain detailed worldwide safety data of a marketed product, and you can know in detail about periodic safety update reports in ICH E2c guideline.
9 What are the signal detection methods used in PV?
Clinical assessment of individual events, Clinical review of collated events, Record linkage, Automated signal detection.