Clinical Research & PharmacovigilancePharmacovigilance

Pharmacovigilance in Clinical Research

All of us have fallen sick at some point in our lives and all of us have taken medicines to get ourselves cured! When we pop in those pills purchased over the counter we consume them assuming that they are safe. Why do we assume so? and who checks whether the drug is actually safe and does not cause any major side effects?
To give you the answer it is the regulatory authorities all across the world who make sure that the drugs that they approve for marketing are safe and effective. How do they do that??? Well, drugs before coming to market undergo rigorous clinical trials i.e. the drug is tested in healthy volunteers and diseased individuals over a number of years usually 8-10 years before the drug becomes available in the market. This testing phase of 8-10 years before a new drug can make it to the market is divided into three stages which are referred to as phases (Phase I to Phase III)…Once the new drugs get the marketing approval after Phase III from the regulatory authorities the testing is not over. The testing for safety continues in the next phase called Phase IV also referred to as post marketing surveillance (PMS). Safety of the new drug is assessed in all these phases and this specialized function in the pharmaceutical industry which deals with detecting, assessing, understanding and preventing side effects (both long and short term) of medicines is called pharmacovigilance.

New drugs are studied during clinical trials from phase I to phase III in controlled conditions i.e. predetermined patient population, procedures and methodology, in limited number of patients. As such there is a high chance that only limited number of adverse events get reported during these phases. Even serious side effects such as liver damage may go unnoticed because of the limited patient numbers. For this reason it is extremely critical and important to keep monitoring the safety of drugs once they hit the market as the patient population consuming the drug is now very large and that too in uncontrolled conditions. Any adverse reaction come across for any drug is reported by physicians or even general public to respective national pharmacovigilance center or the manufacturer of the drug. Significant number of adverse events reported for any new drug can lead to the drug being recalled by the regulatory authorities and making it go off the shelves.

More and more pharmacovigilance work is being outsourced to India by global pharmaceutical companies and job opportunities are tremendous. Aspirants can confidently look at pharmacovigilance as a career option with a bright future ahead of them! James Lind Institute offers an industry specific online pharmacovigilance course that can be a huge boost for your career. To know more about this pharmacovigilance course feel free to click here.

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