Pharmacovigilance Frequently asked interview questions for freshers and experienced.
Hey, Hi …
If you are looking for pharmacovigilance frequently asking questions, then you have landed on the correct page.
Here, I have given you some frequently asked questions and their answers for the pharmacovigilance interview. I have gathered the questions and there answers as per my experience. Most of the questions I have faced in cognizant and TCS interviews.
And a few other questions and their answers were gathered from my friends and some from internet research. I hope this will help you in the upcoming interview.
The ultimate goal of this activity is to help every one of you and also improve your knowledge regarding the pharmacovigilance domain.
What is Pharmacovigilance?
It is the science which deals with the study of the collection, detection, assessment, monitoring, and prevention of treatment adverse event and any other drug-related problem.
What is the adverse drug reaction?
Adverse drug reaction (ADR) is a noxious and unintended effect. It has a relationship with drug action. ADR is a harmful effect that occurs at a normal dose and normal use.
What is an adverse drug event?
Adverse drug event (ADE) is any untoward medical occurrence when a medicine is administered to a patient. It is an unexpected and unpredictable reaction, which does not necessarily have a causal relationship with drug action.
What are different seriousness criteria or How many different serious criteria are there and which are they?
Currently, any event is characterized in total of six seriousness categories and they are:
Death
Life-threatening
Hospitalization or prolonged hospitalization
Congenital anomaly
Disability
Medically significant
Why medically significant called medically significant?
Any adverse event which required medical intervention and which does not fit into the other seriousness criteria due to which medically significant called medically significant.
What are the minimum data elements required for a valid case or what are the criteria for any ICSR?
An identifiable reporter (Patient/Doctor/Pharmacist etc.),
An adverse event,
An identifiable patient
and an identifiable suspect product.
What is SUSAR?
SUSAR is suspected unexcepted serious adverse event.
What are different types of SUSAR or How many different types of SUSAR and which are they?
There is a total of two types of SUSAR. And they are 07-day SUSAR and 15-day SUSAR.
What are the different steps in case processing?
Below are the different case processing steps:
Case receipt.
Case Triage and Initiation.
If the case was valid then this case disposed of for processing.
After case processing, this case should send for medical review (MR).
After the medical review case should send for quality review (QR).
Here, in some instances after case processing the case first send to QR workflow then MR workflow.
If the case was invalid then such cases can directly send for QR to confirm the validity and then pre-archive.
What is the full form of MedDRA?
The full form of MedDRA is Medical Dictionary for Regulatory Activities.
What is the use of MedDRA?
MedDRA is used for coding the adverse event, Indication, patient history, and concurrent condition.
When the MedDRA is updated?
MedDRA is updated twice every year.
In every year of March- April and September-October MedDRA updated.
Explain the hierarchy in MedDRA.
System Organ Class (SOC)
High-Level Group Term (HLGT)
High-Level Term (HLT)
Preferred Term (PT)
Lower Level Term (LLT)
What is Signal in pharmacovigilance?
Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously.
Usually, more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information.
Who should report Adverse Drug Reactions?
All health-care professionals, including doctors, dentists, pharmacists, nurses, and other health-care professionals were requested to report all suspected adverse reactions to drugs (including vaccines, X-ray contrast media, traditional and herbal remedies), especially when the reaction is unusual, potentially serious or clinically significant.
It is vital to report an adverse drug reaction to the drug regulatory authority.
When do you consider a case to be medically confirmed?
A case is considered to be medically confirmed if it contains at least one event confirmed or reported by an HCP (Health Care Professional)
Note: HCP can be a Physician, Nurse, Pharmacist.
What do you mean by causality?
Causality is the relationship between a set of factors.
In Pharmacovigilance, causality is the relationship between the suspect product and the adverse event, like Related, Unrelated, not reported, and not applicable.
What should a Safety narrative consist of?
A narrative should consist of precise and concise information about the
source of the report,
Reporter profession,
Protocol (Other than spontaneous cases)
Patient demographics included patient’s medical history, concomitant and past medications, suspect product and therapy details, treatment details, laboratory, and diagnostic test, and adverse event details which should be chronologically written.
What do you know about the Thalidomide disaster?
In the 1960s, Thalidomide used as a mild sleeping agent and to treat morning sickness in pregnant women.
The major side effect of this drug was Phocomelia (severe Birth defects affecting the upper and/ lower limbs and fetal death. Thousands of babies affected by the malformed limbs.
What do you know about the Tuskegee Syphilis Experiment?
It was an unethical study. The researcher (Doctors from Public Health Services) included the Tuskegee (a city in Macon country, Alabama, United States) sharecroppers without giving the proper information about the study.
This study was started in 1932 to know the disease progression of syphilis (a sexually transmitted disease). This study was continued up to 40 years. The study involves 399 latent syphilis patients and 201 normal healthy people as a control- they were being infected with a variety of ailments of bad blood.
Syphilis patients are left untreated for knowing disease progression even though penicillin recommended treatment is available for syphilis from the year of 1947. Nearly most study participants are injected with syphilis infection.
At the end of the study, most of the study participants were died with syphilis or with its related complications, and their wife’s and children infected with syphilis.
What are the ICH guidelines related to Pharmacovigilance?
ICH E2A to E2F guidelines deals with pharmacovigilance.
E2A guidelines for Clinical Safety Data Management:
These guidelines deal with the terminology and standard definitions related to clinical safety reporting.
It also provides the guidelines on ADR rapid/expedited reporting mechanism during the investigational drug development phase.
E2B guidelines for Data elements transmission of ICSRs.
It provides guidelines on clinical safety data management and ICSR data elements transmission.
E2C Periodic benefit-risk evaluation report.
It provides guidelines on PSURs of marketed drugs which are having a role in benefit-risk evaluation.
E2D It provides guidelines for Post-approval safety data management.
E2E It provides guidelines on Pharmacovigilance planning.
E2F Development Safety Update Report (DSUR):
It provides guidance on DSUR.
It is the data from the Investigational drugs in the clinical trials with or without having a market approval.
Sponsors required to submit DSUR every year.
Explain different phases in clinical trials?
There were four phases involved in the Clinical Trials.
Phase I In this phase (20-100) volunteer was tested. This phase determines the drug safety and dosage with the help of pharmacokinetics of the drug. Except for chronic disease (AIDS/Cancer) drugs, most of the remaining drugs tested in healthy volunteers.
Phase II In this phase (100-1000) volunteer was tested. This phase starts to find out the effectiveness of the drug along with its side effects.
Phase III This phase tested on a huge number (1000 to 10000) of patients. Before going to the drug in the market, this phase confirms/ verifies the effectiveness of the drug in the trial.
Phase IV In this phase the drug enters the market and called post-marketing surveillance.
Note: Phase 0 also belongs to the clinical trial phase known as micro-dosing. A very small amount of the drug is administered in the human body to check whether the drug is behaving the same as it is tested in the animals in the preclinical studies.
Below are some more pharmacovigilance interview questions for your preparations.
What is good pharmacovigilance practices (GVP)?
When GVP guidelines were implemented and which of the modules are relevant for ICSR?
What does E2B mean and what does E in E2B stand for?
Name the regulatory of the US, Canada, Japan, Germany, China, Switzerland, France, Canada, Denmark, Italy, etc.
What is causality and what are the different scales used?
What is expectedness and what is listedness and the difference between them (if any)?
What is an inverted Black triangle in Pharmacovigilance?
What is the Pharmacovigilance Programme of India (PvPI)?
When PvPI was started in India?
What is the National coordinating center for Pharmacovigilance in India?
Mention any two scales used to perform a causality assessment?
When you can send any case for deletion?
What are the special case scenarios?
What is off-labels use in pharmacovigilance?
What is the different actions taken?
What are the different databases you know in pharmacovigilance?
What are de-challenge and re-challenge?
What is the difference between labeled, listed, and expected?
What are the validity criteria in literature cases?
What are the different agreements in pharmacovigilance?
What are the SLA and KPI in the pharmacovigilance business?
What happens if you make any error in case processing?
I tried to include most of the questions asked during an interview with Pharmacovigilance for freshers and experienced. However, maybe I forget to mention some questions.
Hope this helps you...
Prepare Well and good luck.
