In every interview that you might attend, you always wish to know the questions beforehand. However, you should keep in mind that the panel sitting in front of you is experienced and can go a step higher if you can steer clear from their simple volleys. In this article, we have tried to cover top Pharmacovigilance Interview Questions and Answers For Freshers.
No list of questions or guides is perfect but they all are for the preparation of better good. We bring forth to you a list of few academic questions that might make the tortuous path a little easier.
This is a list of questions in a theoretical way although you will have to twist the sentences during the interview.
What is Pharmacovigilance?
Pharmacovigilance could also be is a collecting, monitoring, researching, assessing, and evaluating information which is provided by “WORLD HEALTH ORGANISER (WHO)“and patients o patients on the adverse effects on medicines, biological products, herbalism, and traditional medicines
What is an Adverse Drug Event (ADE)?
An untoward medical occurrence which can be present in a patient during treatment or clinical investigation that’s a related pharmaceutical product.
What is that difference between an ADE and ADR?
The full name of ADE and ADR is Adverse drug event and adverse drug reaction. They’re both adverse occurrences. Adverse drug reaction finds the causality for adverse but on another hand adverse drug reaction. fails to seek out causality for the adverse occurrence
What are the minimum criteria required for a legitimate case?
1. A suspect product
2.An identifiable patient
3. An identifiable reporter
4. An adverse drug event
What do you mean by causality?
Causality means the relationship between a set of factors. It is the relationship between the suspect product and the adverse drug event.
When does one consider an occasion to be serious?
If any event is associated with any one of the following, it can be considered as a serious
- Life threatening
- Hospitalization or prolongation of hospitalization.
- Congenital anomaly /Birth Defect
- Requiring intervention to prevent permanent damage or impairment
- Medically significant
What do you know about ICSR?
The full sort of ICSR is Individual Case Study Report. Basically, it depends on healthcare which is provided by World Health Organiser
What are the phases of clinical trials?
Clinical trials have 4 phases
Phase 0 – It is done with a very small number of people. Experts use minimal number of doses It is not harmful to human.
Phase I – It is done in small group of 15 to 30 people.
Phase II-It is done in large number of people.
Phase III-It involves in several hundred to several thousand patients.
What is the yellow card in pharmacovigilance?
A yellow card was founded by Bill Inman in 1964. It is collecting information suspected adverse drug reactions (ADRs) to medicines.
Definition of the the quantity 9A?
It wants, processes, roles and activities within the discipline of pharmacovigilance for Competent Authorities of medicinal products and Marketing Authorisation Holders (MAH) for use in human. It includes worldwide agreements which sent inside the framework of the International Conference on Harmonisation (ICH).
It has four parts. we discussed following
Part I -It is Marketing Authorisation Holders.
Part II- it’s Competent Authorities and thus the Agency;
Part III-It presents the principles for the electronic trade of pharmacovigilance within the EU
Part IV-It presents Guidelines on pharmacovigilance communication
When does anyone consider a case to be medically confirmed?
When a case or event confirmed by Health Care Professional (HCP).It means a physician, nurse, pharmacist, coroner or psychologist.
What do I mean by MedDRA?
MedDRA means Medical Dictionary for Regulatory Activities.
Abbreviations name of the subsequent
ADE-Adverse Drug Event.
ADR-Adverse Drug Reaction
ESTRI-Electronic Standards for the Transfer of Regulatory Information
HIPAA-Health Insurance Portability and Accountability Act
ICSR-Individual Case Safety Report
PSUR-Periodic Safety Update Report
IBD-International Birth Date
What do I realize about E2a, E2b and E2c guidelines?
E2a-It gives Definitions and Standards for Expedited Reporting.
E2b-It maintain clinical safety data management and also data elements for transmission of individual case safety reports.
E2c- It maintains clinical safety data management and knowledge about Periodic Safety Update Reports for Marketed Drugs
Elaborate on the various sort of Pharmacovigilance (PV)?
It is two types 1. Active PV. 2. Passive PV
1. Active PV-It is active measure which is using to detect adverse events.
2. Passive PV- There’re not any are taken to seem for adverse effects
Definition of the IND approval?
IND means The Investigational New Drug programme of the U.S Food and Drug Administration. Basically, the drug company obtains authorization to send an experimental drug across state lines.
Name The Regulatory Bodies In UK, USA, Japan and India?
UK: European Medicines Agency (EMEA).
USA: US Food and drug administration (USFDA).
Japan: Ministry of Health, Labour and Welfare (MHLW).
India: Central Drugs Standard Control Organization (CDSCO)
What is EudraVigilance?
The European Union data-processing network and management system developed by the European Medicines Agency (EMA) to support the electronic exchange, management, and scientific evaluation of Individual Case Safety Reports associated with all medicinal products authorized within the European Economic Area (EEA). It also incorporates data analysis facilities.
Difference between NDA and ANDA?
Full name of NDA is New Drug Application. When the sponsor of the new drug believes that evidence of the drug’s safety has been obtained to satisfy the FDA’s requirements for the marketing approval the sponsor submits to the FDA replacement drug application.
What are the due dates of safety reporting?
Due dates of safety reporting are 7 days for IND Reporting and 15 days for NDA Reporting.
Explain the hierarchy in MedDRA.
1.System Organ Class (SOC)
2.High Level Group Term (HLGT)
3.High Level Term (HLT)
4.Preferred Term (PT)
5.Lower Level Term (LLT)
What may be a signal?
It is the relationship between an adverse event and a drug that is being unknown or incompletely documented previously. Quite one single report is required to get a sign It depends upon the seriousness of the event and therefore the quality of the knowledge.
What is the Pharmacovigilance Programme of India (PvPI)?
The Central Drugs Standard Control Organisation (CDSCO). New Delhi has introduced a nation-wide pharmacovigilance program under the aegis of the Ministry of Health & Family Welfare, Government of India. The National Coordinating Centre (NCC) is working under the supervision of the Committee to recommend procedures and guidelines for regulatory interventions in India.
Name Some Data Elements In ICSR?
It has three parts
Patient demographics which is said to age, gender and race. Suspect product details which are said to drug, dose, dosage form, therapy dates, therapy duration and indication. And adverse event details which are said to the event, event onset date, seriousness criterion, event end date and latency.
What Should A Narrative Consist Of?
A narrative contains important and concise information that is said to the source of the report, patient demographics, patient’s medical history, concomitant medical record, suspect product details, and adverse event details in an orderly manner.
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