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19 Pharmacovigilance_Basic Interview
Jun
2014
WELCOME PHARMA
STUDENTS
Questions (BIQs)
Pharmacovigilance_Basic Interview Questions (BIQs)

Where to Study?
CLINI INDIAAcademy for Clinical Research and Management

104 EPIP Zone, Level 2, Prestige Omega,
Whitefield, Bangalore
www.cliniindia.com
http://blog.cliniindia.com
For detail mail to cliniindiabangalore@gmail.com

or Call on 0806771 0643, 0805 004 0004
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.
2. What is the minimum criterion required for a valid
case?
a. An identifiable reporter
b. An identifiable patient
c. A suspect product
d. An adverse drug event
3. What is an Adverse Drug Event (ADE)?
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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.
4. What is an Adverse Drug Reaction (ADR)?
An adverse drug reaction is a response to a drug
which is noxious and unintended and which occurs at
doses normally used in man for prophylaxis,
diagnosis, or therapy of disease or for the
modification of physiologic function. Note that there
is a causal link between a drug and an adverse drug
reaction. In sum, an adverse drug reaction is harm
directly caused by the drug at normal doses, during
normal use.
5. What is the difference between an ADE and ADR?
There may not be a causal relationship between a
drug and an ADE, whereas, there is a causal link
between a drug and an adverse drug reaction.
6. 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
7. 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)
8. 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).
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Volume 9A is presented in four parts:

Part I deals with Guidelines for Marketing
Authorisation Holders;
Part II deals with Guidelines for Competent Authorities
and the Agency;
Part III provides the Guidelines for the electronic
exchange of pharmacovigilance in the EU
Part IV provides Guidelines on pharmacovigilance
communication.
9. 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).
10. 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.
11. 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.
12. What should a narrative consist of?
A narrative should consist of precise and concise
information about the source of report, patient
demographics, patients medical history, concomitant
medications, suspect product details and adverse
event details in an orderly manner.
13. What do you mean by MedDRA?
Medical Dictionary for Regulatory Activities.
14. 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)
15. Abbreviations
a. SUSAR
Suspected Unexpected Serious Adverse Reaction
b. SAE
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Serious Adverse Event

c. CIOMS
Council for International Organizations of Medical
Sciences
d. ADE
Adverse Drug Event
e. SSAR
Suspected Serious Adverse Reaction
f. ADR
Adverse Drug Reaction
g. ICSR
Individual Case Safety Report
h. PSUR
Periodic Safety Update Report
i. ICH
The International Conference on Harmonisation of
Technical Requirements for
Registration of Pharmaceuticals for Human Use
j. HIPAA
Health Insurance Portability and Accountability Act
k. ESTRI
Electronic Standards for the Transfer of Regulatory
Information
l. IBD
International Birth Date
16. 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.
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LEARN MEDICAL CODING

Pharmacovigilance_Basic Interview Questions (BIQs)

CLINI INDIAAcademy for Clinical Research and Management

For detail mail to cliniindiabangalore@gmail.com

Facebook Twitter Google+

Any untoward medical occurrence in a patient or

Volume 9A is presented in four parts:

Serious Adverse Event

JOBS FOR M. PHARM AND B.

Vacancy for B. Pharm/ M Pharm/

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