1. Journal of Advanced Pharmaceutical Technology & Research • Volume 5 • Issue 1 • January-March 2014 • Pages 1-***
JAPTR
ISSN 2231-4040
Journal of
Advanced Pharmaceutical
Technology & Research
An Official Publication of Society of Pharmaceutical Education & Research
Vol 5 / Issue 1 / Jan-Mar 2014
www.japtr.org

2. Guest Editorial
Pharmacovigilance: Curriculum and career
Drug related deaths account for the fourth largest category
of mortality in the United States.[1] In addition, in USA,
estimated total cost of medication errors and adverse drug
reactions (ADRs) exceed 136 billion dollars annually.[2]
Although such accurate figures are not available for this
category of mortality in India, a logical estimate may place
drug related deaths very high in this country as well. This
and this fact alone tell us that pharmacovigilance (PV) must
be an integral part of the drug development during clinical
trials and the actual use of the drug in patient population
post marketing.
The World Health Organization (WHO) defines PV as the
science and activities relating to the detection, evaluation,
understanding and prevention of ADRs or any other
drug‑related problems. ADRs (especially the serious ones),
medication and prescription errors and poor products
qualities are the major reasons and areas of the practice of PV.
Thus, risk management, risk mitigation plans and discovery
of toxic signals from data mining of existing safety data bases
are extremely important activities during both development
and post approval phases in the life cycle of a drug.[3]
From 2007 onwards, both EMA and USFDA have
empowered their agencies such that right now
registration of any drug product in the USA and
European countries is impossible without a thorough
post marketing PV program (along with pre‑marketing
risk management plan).[4] An essential part of a proper PV
program is also to maintain huge safety data bases. Such
data bases often contain several million individual safety
records of large pharmaceutical companies’ marketed
drugs, for example. Such requirements of maintaining
very large data bases alone have prompted these firms to
look for cost‑effective PV set ups in economically emerging
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DOI:
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countries like India. Thus pharmaceutical MNCs require
trained professionals for their PV data bases and related
activities. The national PV programs as guided by WHO
are also major hubs of PV activities wherein very specific
and relevant curricular training and experience are
required. It is interesting to note that the outsourced PV
activities to India is on the rise for last 3 years or so even
as the overall clinical trial activities coming to India are
on a decline for the same period.
A career in PV requires adequate qualifications, proper
training and also an employment which has both short and
long term prospects. The basic qualifications for adapting to
a PV career include undergraduate and/or graduate degrees
in human and veterinary medicine, pharmacy, nursing or
allied health sciences. Direct exposure to collection and
organization of PV data, their processing and analyzes and
further implications are required for anyone aspiring for
such a career. There are at least half a dozen institutions in
India where one can attend a course of duration of 1‑2 years
following graduation with an appropriate degree to get an
initial orientation, exposure to some data and case studies
and preparation for a real job. Needless to say, on the job
training and experience offer the most significant portion
of career motivation and insight.
The central theme in a PV career revolves around providing
comprehensive medical, safety and analytical services.
Such services include medical evaluation, assessment
of expectedness and drug‑ADR associations, casualty
assessment, case narratives and processing, use of
medical dictionaries, data mining and signal detection,
medication error related activities and finally some
specialized services. While the hard core knowledge
base (e.g., medical or pharmacy) is essential, a good
familiarity over data management, data base construction
and data mining are additional huge assets in such
careers. Specializations in PV include data collection
and organization, safety administration and evaluation,
regulatory submissions, data mining and unknown toxic
signal identification etc.
Currently, pharmaceutical companies, CROs, IT firms,
KPOs and consulting firms are the ones who are offering
Journal of Advanced Pharmaceutical Technology & Research | Jan-Mar 2014 | Vol 5 | Issue 1

3. Chakraborty: Pharmacovigilance: Curriculum and career
bulk of the PV positions as jobs in India. The regional PV
centers and hospitals could be other major sources of finding
the type of job being discussed here. These latter sources
would not only provide some PV jobs, they can potentially
open up a very caring side of the pharmacy and medical
profession and reduce the gap between the taught syllabus
and professional practice to serve the society.
Dr. Bhaswat S. Chakraborty
Senior Vice‑President and Chairman, Research and
Development Core Committee,
Cadila Pharmaceuticals Ltd.,
Dholka, Ahmedabad, Gujarat, India
E‑mail: drb.chakraborty@cadilapharma.co.in
J. Adv. Pharm. Technol. Res.
REFERENCES
1. US FDA. ADRs: Prevalence and incidence. Available from:
http://www.fda.gov/drugs/developmentapprovalprocess/
developmentresources/druginteractionslabeling/ucm110632.htm
[Last accessed on 2014 Jan 20].
2. Johnson JA, Bootman JL. Drug‑related morbidity and mortality.
A cost‑of‑illness model. Arch Intern Med 1995;155:1949‑56.
3. Gavali DK, Kulkarni KS, Kumar A, Chakraborty BS. Therapeutic
class‑specific signal detection of bradycardia associated with
propranolol hydrochloride. Indian J Pharmacol 2009;41:162‑6.
4. Härmark L, van Grootheest AC. Pharmacovigilance: Methods,
recent developments and future perspectives. Eur J Clin Pharmacol
2008;64:743‑52.
How to cite this article: Chakraborty BS. Pharmacovigilance:
Curriculum and career. J Adv Pharm Technol Res 2014;5:2-3.
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