If you have little idea about what is Pharmacovigilance, you must know that it is concerned with two outcomes: safety and efficacy. If drug works and whether it is safe? It, in fact, touches almost every aspect of the drug lifecycle making it one of the most basic functions within a pharma company.
What is Pharmacovigilance (PV)?
Pharmacovigilance is also known as drug safety, a broad term to describe the collection, analysis, supervising and prevention of adverse effects of drugs and therapies.
What is an adverse reaction?
An adverse reaction could be any reaction to a patient’s body due to a drug or test molecule, in other words, a side effect. A serious adverse effect could be life-threatening that can cause hospitalization, permanent damage or in extreme cases, death.
The role of Pharmacovigilance is to determine the adverse effects collide with a drug’s efficacy. In simple words, to analyze which side effects are worth the risk to patients in comparison to its effectiveness in treating a disease. For instance, chemotherapy causes several and serious side effects but in case of life-threatening cancer, these side effects are considered acceptable in comparison to the potential cure to a patient. But, if there is a drug used to cure a headache caused similar side effects, the risk would be considered greater and the benefit is not enough to justify the potential damage.
What are the main areas of Pharmacovigilance?
Pharmacovigilance is a huge area, but it can broadly be divided into four main sub-areas:
Qualified Person for Pharmacovigilance (QPPV)
For the drug safety professionals, there are several Pharmacovigilance jobs available owing to the various types of companies within the life sciences, which includes global pharma, small pharma companies, generics companies, health authorities drug safety consultancies. Each provides with different opportunities but in every case, there is adequate scope for professionals to progress their PV career.
Why is Pharmacovigilance important?
PV is quite an essential function within a life science company as above mentioned the reason of its significance. To develop a market and commercialize a drug, a company must follow strict regulations which mostly focus on the patient’s safety.
We know that drug safety confirms that a patient’s safety and well-being is primary and is well guarded throughout the entire development lifecycle of a drug or a therapy.
There is continuous vigilance which means that, besides others in the business, senior leaders within a drug safety team have a responsibility and authority to recommend if a development process is to be stopped, or that an approved drug is pulled away from the market.
In several ways, drug safety keeps the pharmaceutical companies moving on. Moreover, the influence and value which this division can add to other business aspects are tremendous.
If you are interested in this area of clinical research, then you must pursue both certificate and diploma courses.
A certificate course in PV and Pharmaco-epidemiology is offered by Symogen, a KPO, and can be done in 4 months.
A post graduate diploma programme in PV is offered by the Institute of Clinical Research, India. It is a one-year course which costs Rs. 1.3 L. Training is provided by expert international and national faculty with several years of experience in both practical and theoretical aspects.
You might be eligible for a course in Pharmacovigilance if you are any one of the following:
Graduate in Pharmacy and Bio-Sciences
Medical Professional (Doctor in all disciplines)
Graduate in pharmacy and biosciences
Junior professional in Pharmaceutical industry, IT Industry and CROs.
For Pharmacovigilance course in Pune, check out here.
Role of Pharmacovigilance in the future
There is a significant shift in Pharmacovigilance owing to some changes in legislation. The new legislation has emphasized more on patient safety which means that Pharmacovigilance has to play more of a central role.
It is a fact that PV will continue to play a vital and much significant part in the development of new drug and therapies, as the core of the medical science mission continues to improve and save the lives of patients across the world.
If you are interested in Pharmacovigilance jobs, you need to her properly trained and earn experience. You can check out for here for Pharmacovigilance training in Pune. There are also some institutes who offer good Pharmacovigilance diploma courses in Pune, stay connected with us to get more insight about Pharmacovigilance and its scope now and in future.
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