India’s
pharmaceutical business is growing rate of 12–14% per annum. It is emerging as a
major hub and pharmacovigilance is in the spotlight for healthcare industry.
Pharmacovigilance (PV) plays an important role by monitoring the adverse
effects of medical drugs throughout the drug development process, clinical
trial and even when the drug is marketed. Pharmacovigilance is also abridged as PhV
and in layman’s terms, it is drug safety. The World Health Organization (WHO)
defines “PV as the science and activities relating to the detection, assessment,
understanding and prevention of adverse effects or any other drug-related
problem”. PV involves rigorous monitoring and that might lead to
withdrawal of many drugs from market or may prevent their commercialization in
market at times.
PV
course promotes clinical training and understanding of the risks and benefits
of medicines, adverse events reporting, consumers and regulators on use of
drugs. It also involves proactive reporting on the quality, safety and efficacy
of medicines. The course covers key aspects of career which includes adverse
event reporting, report writing, early signal detection, narrative writing,
seriousness criteria assessment, risk-benefit management, information on
regulatory bodies involved country wise.
Benefit of Opting Pharmacovigilance as a Career
Option:
PV is a well-defined employment option for medical,
life science and pharmacy graduates with numerous opportunities. It is due to
the pharmacovigilance professionals’, that drugs in the market are safe for
consumption and harmful drugs are often withdrawn from the market. Globally,
many pharmacovigilance centers are working towards drug safety and are
maintaining large databases. which pushes the pharmaceutical companies to
outsource their work to countries like China, India etc. for cost
effectiveness. This provides an opportunity to get jobs in various
pharmaceutical companies and earn attractive package.
Responsibilities of Pharmacovigilance
Professionals:
- Serves as the main link between pharmaceutical company and healthcare experts to provide valid information on drug safety
- Ensures that drugs are safe for patients and identifies any new safety information (signal)
- Handles adverse event in safety database
- Flags up early warning signs of adverse effects of drugs
Firms that appoint Pharmacovigilance
Professionals:
Pharmacovigilance students
can find enormous employment options in the following organizations:
- Contract research organization (CROs)
- Pharmaceutical companies
- Biotechnology firms
- Regulatory authorities and drug safety consultancies
- Regional pharmacovigilance centers and hospitals
- Knowledge process outsourcing (KPOs)
Average Pay-scale in PV:
- Fresher: Rs. 20k-45k
- After 5 years: Rs. 80k-1 lakh
- After 10 years: earn up to Rs. 3 Lakh
Opportunities
in Pharmacovigilance
Figure 1:
Career Ladder in Pharmacovigilance
PV offers jobs in report processing,
in literature search and medical review, aggregate report preparation,
screening and reporting, pharmaco-epidemiology, and risk management, labelling
etc.
Courses
Offered:
The
government is also supporting and emphasizing institutes to train students on
PV as they can understand adverse effects of pharmaceuticals and work for human
wellbeing. There is huge need for well qualified and trained people who could take
PV jobs in drug companies. If a student or professional needs to strengthen
his/her resume, there are specialized certificate and diploma courses to grab
better opportunities.
Turacoz Skill Development
provides up-to-date training to professionals and students who would like to
opt for various opportunities in PV. The courses provided by Turacoz are:
Professional
diploma in pharmacovigilance
Post graduate
diploma in pharmacovigilance & medical writing
Post graduate
diploma in scientific writing & clinical research
These
courses have been planned by pharma experts from the industry themselves and
thus it covers whole pharmacovigilance theoretical and practical knowledge for
industry. The primary aim of the Post Graduate Diploma Program in
pharmacovigilance is to familiarize the student with the updated theoretical
and practical aspects in Pharmacovigilance. Students enrolled in online and
offline certificate courses will be given exposure to practical exercises,
training in detection of signal, data entry in database. Thus, in these courses
students and professional will get maximum exposure to practical skills
required in PV planning and execution.
Conclusions:
PV is a great employment option for pharmacy, medical
and life science graduates. A
career in PV requires suitable qualification and proper training
for processing and analyzing data. The PV course provides adequate knowledge
and up-to-date training to students who would like to opt for various career
opportunities in PV. The skill development program and training in PV is
important and are provided by various institutes in India. The course module
covers basic principles of pharmacovigilance, regulatory compliance, quality
assurance, safety monitoring and all the key aspects in PV. These courses are
designed for the aspiring students to make their career in PV as they get
maximum theoretical and practical exposure via course.
Author:
Author:
Aayushi Ambastha
