In today’s competitive pharmaceutical and research industries, getting our desired work position is challenging. The pharmacovigilance industry is growing at a rapid speed in India, creating various opportunities for professional development for doctors, pharmacists, and life sciences graduates. The obvious reasons include career advancement, competitive compensation, a positive work environment, and industry demand.
Preparing for a pharmacovigilance job requires particular qualifications and training. Enrolling in a specialized Pharmacovigilance course, such as those provided by CareerInPharma, can greatly improve your profile. These courses are customized to industrial requirements and cover both theoretical foundations and practical implementations. Your CV is your first step towards success. A CV highlighting pharmacovigilance training, certificates, or relevant coursework has a better chance of being shortlisted. Combining these credentials makes you a strong applicant in the eyes of recruiters.
Interview preparation is essential for landing a position in pharmacovigilance. Understanding frequently asked questions and industry standards may help you gain a competitive advantage. Next, you’ll be wondering what pharmacovigilance interview questions the interviewer will ask. Our training programs frequently include mock interviews, which provide insight into the hiring process. Check out a few pharmacovigilance job interview questions.
Pharmacovigilance Job Interview Questions
Hiring managers may ask this question to assess your knowledge, understanding of necessary duties, and alignment with the job criteria. Based on theory concepts, regulatory guidelines, technical and analytical questions and answers are as follows:
1. What is Pharmacovigilance?
According to the WHO, Pharmacovigilance is “The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problem.”
2. Why is Pharmacovigilance Required?
Promoting the safe and effective use of medicinal products, in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals, and the public. Pharmacovigilance is, therefore, an activity contributing to the protection of patients and public health.
3. What is an Adverse Drug Reaction (ADR)?
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, of which the World Health Organization (WHO) and the United States Food and Drug Administration (FDA) are members, defines an ADR as “A response to a drug which is noxious and unintended, and which occurs at doses normally used for prophylaxis, diagnosis, or therapy of disease or the modification of physiologic function.”
(Or)
An adverse drug event is defined as: “Any untoward medical occurrence that may present during treatment with a pharmaceutical product, but which does not necessarily have a causal relationship with this treatment.
4. What is an Adverse Drug Event (ADE)?
An adverse event is any undesirable experience associated with the use of a medical product in a patient.
5. What is SUSAR?
SUSAR stands for Suspected Unexpected Serious Adverse Reaction. A SUSAR is a serious ADR whose nature or severity is unexpected based on the applicable product information.
6. What do you mean by Causality?
In pharmacovigilance, causality refers to the relationship between the suspect drug and the adverse drug event.
7. What is Risk Management?
Risk management in pharmacovigilance is undertaken to promote the safe use of medicines and safeguard the health of patients. It is a set of activities performed for identification of risk, risk assessment, and risk minimization and prevention.
8. What is Informed Consent?
Informed consent is the process of obtaining approval before administering a drug or disclosing personal information.
9. How Do You Maintain Patient Confidentiality?
Patient confidentiality is ensured by following data protection laws, sharing information only with authorized personnel, using encrypted channels, and secure storage systems.
10. What is DSUR?
DSUR stands for Development Safety Update Report. A Development Safety Update Report (DSUR) gives safety information relating to drugs under clinical development. The purpose of the DSUR is to present a comprehensive, annual review and evaluation of pertinent safety information collected during the reporting period related to a drug under investigation, whether or not it is marketed.
11. What are PSURs?
PSURs are Periodic Safety Update Reports, are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorisation.
12. Which Form is Used for Mandatory Reporting in the US FDA?
The US FDA uses MedWatch Form 3500A for mandatory adverse event reporting.
13. What are the Drug Regulatory Bodies in the USA, UK, Japan, and India?
- USA: United States Food and Drug Administration (USFDA)
- UK: European Medicines Agency (EMA)
- Japan: Ministry of Health, Labour and Welfare (MHLW)
- India: Central Drugs Standard Control Organization (CDSCO)
14. What is a Yellow Card?
A Yellow Card is used in the UK to collect ADR information, enabling drug safety monitoring.
15. Which body maintains the SUGAM portal and what is it?
The SUGAM portal is maintained by the Central Drugs Standard Control Organization (CDSCO). The SUGAM portal is an online platform used for the submission of applications and regulatory processes related to drugs, medical devices, and cosmetics in India. It serves as a digital interface for manufacturers, importers, and stakeholders to apply for approvals, and licenses, and track the status of their submissions with the CDSCO.
16. What are the Important Abbreviations
- SUSAR: Suspected Unexpected Serious Adverse Reaction
- CDSCO: Central Drugs Standard Control Organization
- SAE: Serious Adverse Event
- CIOMS: Council for International Organizations of Medical Sciences
- ADE: Adverse Drug Event
- ADR: Adverse Drug Reaction
- ICSR: Individual Case Safety Report
- PSUR: Periodic Safety Update Report
- ICH: International Council for Harmonisation
- MedDRA: Medical Dictionary for Regulatory Activities
17. What Information is Covered in E2A, E2B, and E2C Guidelines?
- E2A: Clinical Safety Data Management: Expedited Reporting Standards
- E2B: Data Elements for Transmission of Individual Case Safety Reports
- E2C: Periodic Safety Update Reports and Periodic Benefit-Risk Evaluation Reports.
18. What is MedDRA?
Medical Dictionary for Regulatory Activities (MedDRA) is a standardized medical terminology developed by the ICH for regulatory use.
19. What is Signal Detection?
Signal detection in pharmacovigilance is the ongoing monitoring of individual case safety reports (ICSR) to identify case reports of adverse events (AE) that are worthy for further exploration.
20. What are the Methods used in Signal Detection?
- EBGM: A measure of association for signal detection.
- ROR: Estimates the likelihood of an adverse event being reported for a particular drug.
21. What is the Hierarchy in MedDRA?
- System Organ Class (SOC)
- High Level Group Term (HLGT)
- High Level Term (HLT)
- Preferred Term (PT)
- Lower Level Term (LLT)
22. What is an orphan drug?
An orphan drug is a pharmaceutical agent that is developed to treat certain rare medical conditions. An orphan drug would not be profitable to produce without government assistance, due to the small population of patients affected by the conditions. The conditions that orphan drugs are used to treat are referred to as orphan diseases. The assignment of orphan status to a disease and to drugs developed to treat it is a matter of public policy that depends on the legislation (if there is any) of the country.
23. What is the latest version of MedDRA in 2024, and how often is it updated?
MedDRA is updated biannually, the latest version of MedDRA is version 27.1, released in November 2024.
24. Which organization is responsible for maintaining and developing MedDRA and how many characters are in a MedDRA code?
MedDRA is maintained and developed by the Maintenance and Support Services Organization (MSSO) and each MedDRA code contains 8 characters.
25. What is VigiBase?
VigiBase, WHO’s global database of reported potential side effects of medicinal products, is regularly screened for possible safety signals requiring further investigation and action to prevent harm to patients. It is maintained and managed by the Uppsala Monitoring Centre (UMC).
Conclusion
The questions above will help you gain knowledge of the subject while also appearing educated in your interviews. If you want to win that job interview, we recommend taking our CareerInPharma pharmacovigilance course and training part in the mock interview examinations.
