What is Pharmacovigilance?
Abbreviated as
PV or PhV, Pharmacovigilance is the science relating
to the detection, assessment, understanding and prevention of adverse effects,
particularly long term and short term side effects of medicines.
Generally speaking, it is the science of collecting, monitoring, researching,
assessing and evaluating information from healthcare providers and patients on
the adverse effects of medications, biological, herbalism and traditional
medicines with a view to:
- Identifying new
information about hazards associated with medicines
- Preventing harm
to the patients.
Why should students opt
for Pharmacovigilance as their career options?
Pharmacovigilance is a great career
option for life science and pharmacy graduates. It is a scientific discipline
that is primarily concerned with reporting and analyzing of drug side effects.
It is primarily due to the work of Pharmacovigilance professionals that the
drugs in the market that we consume are mostly safe and those that are found
harmful are taken off the market. Pharmacovigilance professionals continuously
monitor the safety of the drugs in clinical trials as well as the drugs already
being sold in the market. After a drug side effect is reported, the
Pharmacovigilance professionals enter the event in relevant databases, follow
up with the case to gather more information and forward these reports to
regulatory authorities and other applicable bodies. The Pharmacovigilance professionals
identify signals in data that may point towards a potential side effect and
probe the case further.
About a career in drug safety or Pharmacovigilance
Those seeking a role in drug
safety or pharmacovigilance should hold a life sciences degree or a nursing,
pharmacy or medical degree. There are also postgraduate courses that could be
of benefit to a candidate seeking a role in this sector, such as a Master in
Pharmacovigilance.
This course covers a variety of important aspects of
the career, including reporting, report writing, signal detection and risk
management, as well as providing a thorough understanding of the regulatory
bodies around the world.
For anyone looking to find a job in
pharmacovigilance or drug safety, previous experience in the industry is of
great value. Alternatively, a clinical background and first-hand experience
with adverse reactions can be advantageous so nurses and pharmacists can also
be attractive candidates.
A career in drug safety and pharmacovigilance will
generally start with a position as a drug safety associate, officer, scientist
or coordinator. Responsibilities will then progress to senior specialist or
management roles, often with an in-depth knowledge of a specialty area, such as
medical writing, auditing, medical affairs or quality assurance.
Finding a pharmacovigilance job or drug safety
position abroad can also be a great opportunity for those seeking a career in
this sector and opportunities are prevalent, although generally in the larger
companies.
How has the sector fared so far?
Setting up of stringent laws by
regulatory bodies (e.g. US-FDA, DCGI, EMEA etc.) has led to the adoption of a
systematic Pharmacovigilance framework worldwide. This in turn had led to the
creation of large number of jobs pertaining to this field.
Worth of Pharmacovigilance market
worldwide was US $186 million in 2008 and is estimated to reach US $ 2,253 by
the year 2015.
At present, India is the fourth
largest producer of pharmaceuticals in the world and therefore is a surfeit of
drug brands with more than 6,000 licensed drug manufacturers and over 60,000
branded formulations. India offers unique advantages for the growth of
Pharmacovigilance that include:
- Rapid induction
of New Chemical Entities (NCEs) and high technology pharmaceutical
products in market
- Abundance of
patients with genetic diversity
- Presence of Lakhs
of formulation in domestic market
- Presence of large
number of licensed drug manufacturers in India
- Potentially large
world scale Adverse Drug Reaction (ADR) database
Job description:
A Pharmacovigilance professional
does the following:
- Track all adverse
event reports received and completed;
- Review and assess
all source documents, and compile data in an adverse event report;
- Data enter report
into the safety database;
- Code adverse
events in the safety database;
- Perform labeling
assessment of adverse events, comparing adverse event to adverse events
previously reported and contained in the product label;
- Release report to
safety database
Job prospects:
Starting salaries for freshers
are substantially a function of their educational background, varying from year
to year as well as across organizations and domains.
The following represents the
typical work place hierarchy.
- The Entry level job for life science
graduate is DSA (Drug Safety
Associate). DSAs are mainly involved
in case creation, checking for
MSI ( Minimum safety information – a patient, a reporter, a suspect
drug and a adverse event ), reconciliation
and follow-up process, data entry of all information
available in the document and medical coding
- Once an
individual acquires an experience
of 2-3 years in that position and builds the required skill sets
(Medical coding, narrative and scientific writing, good understanding of
medical terms and basic understanding of regulatory affairs, ICH-GCP and
compliance etc) he can go on to become
a DSS (Drug Safety Scientist).
- Individuals
once having acquired a good
narrative writing experience can pursue it on a larger frame, moving
from individual cases like writing for PSUR(Periodic Safety Update Report) and PADER(Periodic Adverse Drug Experience Reports) and as well as
becoming a Aggregate report
scientist.
- With an overall
of 7-10 years experience in this
position individual can easily become a Team lead or Team manager based on the company.
- Lastly,
individuals end up acquiring the position of a Director or Vice-President with an experience of 9-10 years.
Pay-scale:
- Fresher: Rs
15,000-20,000
- After 5 years: Rs
50,000-60,000
- After 10 years:
More than Rs 80,000-90,000
Growth prospect:
Individuals trained in
Pharmacovigilance will find good job options in the following sectors:
- Pharmaceutical
Companies (MNCs & Indian) & Biotech companies.
- Clinical Research
Organizations.
- KPOs like
Accenture & Quintiles.
- Regulatory
Agencies like DCG (I) & CDSCO
- Pharmacovigilance
units in Medical colleges & Hospitals
Besides this, students might land
up in companies like:
Asian
clinical trials serene, Bioserve, Clin invent, Clintec international,
Clinigene, Dr Reddy’s lab, Elly Lilly, Glaxo smithkline, IGATE clinical
research, Intass biopharmaceuticals, Johnson & Johnson, Lambda therapeutic
research, Lupin limited, Matrix laboratories ltd., Merck, Novartis, Novo
Nordisk, Pfizer, Pharmanet, Quintiles, Ranbaxy, Roche India, Sristek, Siro
Clinpharma, Synchron, Sanofi Aventis, Torrent pharma, Vimta labs, Zydus,
Reliance life science, Amed, Accutest, Actimus, Adroit insights,
Alembic, Asian Clinical Trials.
Some of the best institutes to
study Pharmacovigilance
·
ICRI
(Indian Institute of Clinical Research - India)
·
Catalyst
Clinical Services are
Courses can be pursued to become
a Pharmacovigilance professional
·
ICRI’s
Post Graduate Diploma in Clinical Research and Pharmacovigilance
·
Catalyst's
Professional Certificate in Pharmacovigilance
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