Pharmacovigilance
involves the assessment, detection and prevention of long-term and short-term
adverse effects of medicines. Because of the serious nature of the profession,
it requires expert pharmacovigilance training. As a pharmacovigilance
professional, one would be required to collect, research, monitor and evaluate
information from patients and healthcare workers on the side effects of
medicine in order to discover new hazards of a medicine.
Demand for Pharmacovigilance
Training
The pharmaceutical industry has undergone large scale
globalization and there has been an increasing awareness of drug safety issues.
Because the need for pharmacovigilance in India is expanding as the drug
Research and Development segment is expanding, there is an increased demand for
pharmacovigilance courses. India ranks fourth in the world for the production
of pharmaceuticals with over 6000 licenced manufacturers of drugs and more than
60000 branded formulations. It is also a lucrative industry for clinical trials
and post-marketing surveillance of approved drugs. Pharmacovigilance is
important during the initial years of launch of a medicine when drug safety
information is acquired from a larger patient pool.
Eligibility
for Pharmacoviligance
Course
Any life-science graduate is eligible for
pharmacovigilance training. Doctors, pharmacy graduates and postgraduates, other
professionals from the pharmaceutical industry, clinical research professionals
are also eligible.
Pharmacovigilance
Course Curriculum
Most pharmacovigilance
training courses teach the basics along with risk management, clinical
safety and regulations compliance, safety reports and adverse drug reactions,
regulations concerning clinical trials, pharmacovigilance management and signal
analysis. The aim of pharmacovigilance course is to enable students understand
the benefits and risks of drug use, manifestations of adverse drug effects,
detection of adverse drug reactions, and their associated legal and historical
frameworks.
Career
Prospects after Pharmacovigilance
Training
The pharmacovigilance industry has a huge potential
for growth and success. A pharmacovigilance officer’s role begins right from
the initiation of preclinical studies and extends even after the marketing of
the drug is complete and it is under circulation. The drugs are evaluated for
adverse reactions in a limited pool of patients before being marketed to a
larger pool. It is thus essential to identify and detect adverse drug reactions
of medicines after it is marketed to patients. It is thus essential to pay
great attention to what is taught in a pharmacovigilance course because of the
meticulous nature of the profession. A pharmacovigilance officer is responsible
for detecting, assessing and preventing adverse drug reactions or other
medicine-associated problems and side effects, both in the longer term and
short term. After the completion of pharmacovigilance training, one can be
employed as a Clinical Pharmacovigilance Associate, a Pharmacovigilance
Manager, Regulatory Affairs Associate, Analyst, Pharmacovigilance
Monitor or Pharmacovigilance Officer.
The job profile of a pharmacovigilance
professionals involves tracking of adverse reaction event reports received,
reviewing and assessing source documentation, compiling data in reports on
adverse events, entering data into safety database, coding adverse events in
the database, labelling and comparing adverse events with previously reported
events and releasing reports into the database.
Ikya Global is one of the few best pharmacovigilance training
institutes in Hyderabad that offer training at affordable prices along with
placement assistance and certification.
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