Interview procedure:

1) Aptitude test – General logical, reasoning and mathematical questions. In this test, you will
be given around 45 minutes to answer around 40 multiple choice questions. You can practice by
searching similar type of tests on google.

2) HR round- general introduction about yourself and your educational background

HR Round Expected Questions

Q1) Introduce yourself?

ANS) Start from your name, your native, your family member, brief note on what your parent's
occupation and also about your siblings (if any) and their occupation. Details about where you
did your schooling and other educational details. Brief introduction of your achievements in
school or college life. In case you are a post graduate, then give a brief introduction of your
project during Masters and then little about your social life like your hobbies and other things....
NOTE: Introduction is asked just to see how well you present about yourself. The members
taking your interview will forget about you the moment you stop talking. So be specific about
what you tell about yourself and also about your educational details. It should be precise and
ALWAYS HIGHLIGHT THE POSITIVE POINTS. For eg: any scholarship awarded to you or
any extracurricular activities done by you.

Q2) Why you want to join Quintiles and why Pharmacovigilance?

ANS) Just be diplomatic while answering about the company. You can say that you always
wanted to join this company as you heard a lot of good things about this company from me. and
also that this company is recognized as the top company in CRO industry in employment
satisfaction. And as i was always interested in pharmacovigilance as this helps me utilize my
knowledge appropriately in this than other fields in clinical research.

Q3) what will you do if you get a better opportunity in some other company in terms of
designation or salary?
ANS) For me more than salary, working with a reputed company with job satisfaction is more
important which will help me grow career wise as well as knowledge wise. so i guess i won’t be
changing to some other company no matter what they offer.

Q4) How you see yourself in next 3 years, 5 years and 20 years in your career?
ANS) For first 3 years, being new to this field, i would like to gather all the basic knowledge
related to this field and then after 5 years i would like to grow career wise, maybe to a higher
post. After 20 years, if i am satisfied with what i have achieved in the past 20 years, then i will be
more than happy to retire.

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3) SAE narrative round - Here you will be given an Adverse Event Form (serious). The patient
is hospitalized due to the event and hospital discharge summary will be provided. You have to
combine both Adverse Event form and discharge summary and write in your own words.
Remember to read both the documents properly for some time and then write the summary.
Follow the chronological order and write in short but understandable format.

4) Personal interview (technical) which will be conducted on same day or some other day
depending on the availability of the people who will conduct the interview and the number of
candidates appearing for the interview.

Personal interview (technical) Expected Questions

1) Why you want to join quintiles and why pharmacovigilance?

Ans) Just be diplomatic while answering about the company. You can say that you
always wanted to join this company as you heard a lot of good things about this company
from me. And also that this company is recognized as the top company in CRO industry
in employment satisfaction. And as i was always interested in pharmacovigilance as this
helps me utilize my knowledge appropriately in this than other fields in clinical research.
2) Why PV is need/importance/advantages of PV
3) Define ADR and adverse event, difference between them
4) Health/regulatory authority of countries like US, UK, Japan, India
5) Type of case report eg. SR report, Literature report, PMS , Clinical trial
6) Regulatory timeline of serious and fatal cases
7) Make sure you read ICH E2D guideline
8) In E2D you get the answer of all the above mentioned questions.
9) Tell me about your company PV processing procedure
10) After receiving of a case from reporter, triage process will be done and we will book in
the case. Enter the information in general tab, patient tab, product tab, event tab, narrative
part in analysis tab, activities and additional information. If non-serious case lock the
case or else if a case is serious the case will be forwarded to Sponsor Company.
11) What kind of case types you processed
Ans) In our company we processed spontaneous, Literature, clinical trial reports
12) How you will receive cases from Client end
Ans) By an email, Fax, phone and paper case report.
13) What is MedDRA, WHO Dictionary
Ans) MeDRA is a Medical dictionary for regulatory activities, which is used to code an
suspected event related to drug, indication, clinical investigations.
14) WHO Dictionary is a world health organization dictionary which is used to code drugs.
15) How you are going to differentiate regulatory time lines for Clinical Trial cases and
Spontaneous report cases.

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 16) Regulatory timelines for clinical trial cases are based on causality and
for spontaneous cases it is based on Seriousness.
17) What are the regulatory timelines for non serious, serious and fatal cases
Ans) For Non serious cases regulatory timelines are 30 days
For serious cases regulatory timelines are 15 days
For fatal cases regulatory timelines are 7 days
18) What is Triage Process
Ans) Triage is first level screening of case. After receiving of case, case report will be
date stamped and checked whether case satisfies 4 criterions (Identifiable patient, reporter
details, suspected drug, suspected event). Performs duplicate search and confirm whether
case is a initial or follow up. Triage performs initial assessment of seriousness, causality,
suspectedness and later book in a new case and a new argus id will be created.
19) How you do the labeling to the suspect products
Ans) By using company’s drug core data sheet, labeling can be done. If suspected event
related to company’s drug is listed in core data sheet then it is considered as
expected/listed. If not it is unexpectedness/unlisted.
20) Which version of MedDRA and WHO dictionary are you using and what is the current
version
Ans) MedDRA ---- 14.1. Current Updated Version in Market is:15.0
21) How you will differentiate patient medical history, concomitant medications, treatment
medications and Events, at the time of processing
Ans) Any untoward or noxious experience by the patient on administration of a
therapeutic dose which need not to have a necessary causality relation with drug is called
an event. Based on date of administration of company’s drug by patient, medical history,
concomitant medication treatment can be decided. If an event is prior to administration
date of drug, it is medical history. if a drug has been given to a patient prior to
administration date of drug and still continuing it is called as concomitant medication. If
an event has occurred and medication has been given inorder to treat the condition it is
regarded as Treatment.
22) What is Dechallenge and Rechallange
With drawing of a drug after an event has occurred.
Readminstration of drug after recovery of an event
23) For coding of concomitant medications and treatment medications which dictionary will
you consider?
Ans) World health organization dictionary
24) For coding of Events which dictionary will you consider?
Ans) MedDRA
25) Daily how many cases will you process?
Ans) 6-8 cases, also as per daily cases work load
26) Will you take Dechallenge and Rechallange for concomitant and Treatment drugs or only
for company suspect drug?

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 Ans) No dechallenge and rechallenge are for suspect drug.
27) Which version of Argus are you using?
Ans) ARGUS 6.0
28) Will you do the case corrections for the cases:
Ans) Yes, will do. Whoever did the initial case, they only need to do case correction
29) Will your company do the QC and MR Activity?
Ans) No
30) Till what level your company will have the work flow access?
Ans) Till data entry level only

31) Difference between AE & SAE , AE & ADR, ADR & SIDE EFFECT?
32) What is ICSR?
o PSUR? SUSAR?
33) Current MedDRA version? Which Version you are using MEDRA in your lab?
34) What is narrative
INITIAL RECEIPT DATE
SAFETY RECEIPT DATE
OECHALLEASE
+VE DECHALLASE
-VE DECHALLASE
RECHALLASE
+VE RECHALLESE
-VE RECHELLKESE
35) What is CDD, WHO DD?
36) How many dictionaries using in ARGUS?
37) Tell me data base using in PV?
38) What are the MedDRA hierarchy terms?
39) Define ARISg?
40) What is CIOMS, CDSCO
CCDS-COMPANY CORE DATA SHEET
GCP-GOOD CLINICAL PRACTIC
CRO-Contract Research Organization
41) PSUR Time lines for India, UK, us & Europe?
42) Europe Guide line-E2A, E2B, E2C, E2D, E2E, E2F?
43) ICH Guidelines?
44) What is Belmont Report?54
45) What is Declaration of Helsinki?
46) What is IND? NDA? SNDA?
47) How we can perform duplicate checking?
48) SUSAR Timelines?
49) What is Expedited Reports?
50) What is solicilated & unsolicilated reports?
51) When sulfonamide trapedy occurred?

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 Thliomide trapedy occurred?
52) What is listedness /expectededness/labeled?
53) What is causality?
54) What is core data sheet?
Spc?
Uspi?
Pi?
55) Define ICH? WHICH COUNTRIES INVOLVED?
56) Tell me some regulatory authority names?
UK
US
AUSTRALIA
JAPAN
CANADA
SOUTH AFRICA
SINGAPORE
57) What is AERS?
58) What are the minimum criteria for a valid
59) What are the at risk situations?
60) What is informed consent form?
61) What is off label use?
62) What are black box warnings?
63) What is day zero?
64) Read classifications (pharmacology)
Anti-Parkinson’s classification
Anti-epilepsy drugs
Anti-cancer drugs
Anti-ulcer drugs
Anti depressants
Anti-diabetic drugs
Anti-hypertensive drugs etc
65) What is Stevens Johnson syndrome?
66) For freshers explain your project work?
67) What is UMC? Where it is located?
68) Tell me how you will give event priority/ranking

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