Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.

There are different organizations who providing jobs in pharmacovigilance such as CRO- contract research organizations; in india such as Paraxel , IQVIA, Labcorp etc, also healthcare IT such as TCS, cognizant,accenture etc. And some sponsored oragnizations also provide opportunities in pharmacovigilance.

If we consider interview process of pharmacovigilance then there are different types of interview such as walk in and scheduled.

In walk in there may be aptitude test, group discussion but in both walk in and scheduled interview HR and technical round is common.

Today we will talk about technical round, in technical they will ask questions related to domain knowledge and which is very important round since it check any students understanding for pharmacovigilance.

Here are some of most asked interview questions

Q 1. What is Pharmacovigilance?
Pharmacovigilance is the science of collecting, monitoring, researching, assessing
and evaluating information from healthcare providers and patients on the
adverse effects of medications, biological products, herbalism and traditional
medicines.

Q2. What is the minimum criterion required for a valid case according to WHO?
a. An identifiable reporter
b. An identifiable patient
c. A suspect product
d. An adverse drug event

Q3. What is an Adverse Drug Event (ADE)?
Any untoward medical occurrence in a patient or clinical investigation subject
administered a pharmaceutical product and which does not necessarily have to
have a causal relationship with this treatment.

Q4. When do you consider an event to be serious?
If an event is associated with any one of the following, it is considered to be
serious
a. Death
b. Life threatening
c. Hospitalization or prolongation of hospitalization.
d. Congenital anomaly
e. Disability
f. Medically significant

Q 5. Name the regulatory bodies in USA, UK, Japan and India?
USA: United States Food and drug administration (USFDA).
UK: European Medicines Agency (EMEA).
Japan: Ministry of Health, Labour and Welfare (MHLW).
India: Central Drugs Standard Control Organization (CDSCO)

Q 6. What is Volume 9A?
Volume 9A brings together general guidance on the requirements, procedures,
roles and activities in the field of pharmacovigilance, for both Marketing
Authorisation Holders (MAH) and Competent Authorities of medicinal
products for human use; it incorporates international agreements reached
within the framework of the International Conference on Harmonisation (ICH).

Q 7. 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, coroner or psychologist
(only in Germany).

Q 8. 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
drug event.
• Is there a convincing relationship between the drug and the event?
• Did the drug actually cause the event?

Q9. . Name some data elements in ICSR?
Patient demographics: Age, gender and race.Suspect product details: Drug, dose, dosage form, therapy dates, therapy
duration and indication. Adverse event details: Event, event onset date,
seriousness criterion, event end date and latency

Q 10. What should a narrative consist of?
A narrative should consist of precise and concise information about the source of
report, patient demographics, patient’s medical history, concomitant
medications, suspect product details and adverse event details in an orderly
manner.

Q 11. 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)

Q 12. What do you know about E2a, E2b and E2c guidelines?
E2a: E2a guidelines give standard definitions and terminology for key
aspects of clinical safety reporting. It also gives guidance on mechanisms
for handling expedited (rapid) reporting of adverse drug reactions in the
investigational phase of drug development.
E2b: E2b guidelines for the maintenance of clinical safety data management
and information about the data elements for transmission of Individual
Case Safety Reports.

E2c: E2b guidelines for the maintenance of clinical safety data management
and information about the Periodic Safety Update Reports for marketed
drugs

Q 13. State the benefits of Pharmacovigilance program.
This program will increase the knowledge and importance of
Pharmacovigilance in drug discovery process and Clinical Research,
Pharmacovigilance is becoming an important part of drug development as it
deals with the patients’ safety & efficacy of drug resulted into new job
avenues. The participants after the completion of this would have new
economic pursuits as Pharmacovigilance potential opportunities & growth
prospects are huge.

Q 14. Role of Drug Safety Associate:
Manage and relay d rug safety information, maintain current knowledge of global
drug safety regulations, summaries clinical safety data, participate in meetings
with potential and actual study sponsors, write narratives with medical input from
a physician, report SADRs to the Regulatory Authorities, participate in the training
of operational staff on drug safety issues, quality control work o f other staff in
the department, take on any other task as assigned by the manager or Medical
Director within the capabilities of the Drug Safety Associate.

Q 15. What are the objectives in Pharmacovigilance?
Understanding the concepts of ADR, Medical Errors, Public Health
Significance, Regulatory Interventions, ADR Monitoring schemes.

Q 16. What are the types of Pharmacovigilance (PV)?
A. Two types. 1. Active PV and 2.Passive PV
Active PV: Active (or proactive) safety surveillance means that active
measures are taken to detect adverse events. This is managed by active
follow-up after treatment and the events may be detected by asking
patients directly or screening patient records. The most comprehensive
method is cohort event monitoring (CEM)
Passive PV: Passive surveillance means that no active measures are taken to
look for adverse effects other than the encouragement of health
professionals and others to report safety concerns. Reporting is dependent
on the initiative and motivation of the potential reporters. This is the most
common form of pharmacovigilance. It is commonly referred to as
“spontaneous” or “voluntary” reporting.

Q 17. What are the due dates for safety reporting?
A. Safety reporting due dates are 7days for IND Reporting and 15 days for NDA
Reporting

Q 18. What are Data assessments in Pharmacovigilance?
Data assessments are:
Individual case report assessment
Aggregated assessment and interpretation

Signal detection
Interactions and risk factors
Serial study
Frequency
Estimation

Q 19. What is Spontaneous reporting?
Spontaneous (or voluntary) reporting means that no active measures are
taken to look for adverse effects other than the encouragement of health
professionals and others to report safety concerns. Reporting is entirely

dependent on the initiative and motivation of the potential reporters. This
is the most common form of pharmacovigilance, sometimes termed passive
reporting. In some countries this form of reporting is mandatory. Clinicians,
pharmacists and community members should be trained on how, when,
what and where to report.

Q20 What is WHO ART, WHO DD and MedDRA and the difference between them?
The WHO Drug dictionary (DD), MedDRA and the WHO Adverse reactions
terminology (WHO-ART).
WHODD= used for drug coding
MedDRA, WHO-ART = coding of events

For more information kindly watch this video