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subject: The Necessity And Objectives Of Pharmacovigilance [print this page]


No pharmaceutical company can market a medicine at the whim of a department of theirs; they need to get a Marketing Authorisation for advertising, marketing or selling the drug in the European Union before this. The idea is to ensure that the drug a pharmaceutical company brings to the market is effective and safe for use. Detecting, assessing, understanding and preventing the adverse reactions of medicines are the chief responsibilities of professionals working in this field. If you were considering pharmacovigilance jobs, it is important to understand the necessity, objective and methods involved in this field.

Why is pharmacovigilance necessary? Once a particular medicine passes pre-clinical trials over animals, the clinical trials begin. Usually, the first phase begins with trials on a group of healthy individuals, followed by a trial on a group of individuals with the health problem to be addressed by the medicine. The next phase of the clinical trial involves a more diverse group of people. Medicines are approved once it passes through this set of trials. However, such trials are often incapable of ascertaining long term efficacy and safety as well as effects of the drug on diverse groups of individuals. This is where pharmacovigilance comes in. The task of professionals working in this field is to conduct post-approved studies to ascertain whether the drug meets the efficacy and safety standards.

What are the objectives of this? The primary goal of pharmacovigilance is to contribute to the evaluation of new medicines, including detecting and understanding the advantages, positive and negative effects, efficiency and risks. The responsibility acquires even more importance when it is a new or evolving medical treatment. The underlying objective is improvement of patient care and safety, through the effective and safe use of medicines in public health programs. Betterment of healthcare pertaining to the effective (cost effective also comes within the scope) and safe use of medicines is the chief responsibility of the professionals opting for these pharmaceutical jobs.

Who are the active participants in this field? Apart from the government and the pharmaceutical companies, many other entities are also associated with this study of medicine in the post-approved phase. Hospitals and healthcare facilities, medical associations, medicine information centres, patients and consumers, and certain other entities are involved in the studies. Close collaboration between the entities ensures proper management of drug use. It ensures future development in the science and practice of this domain. This also enhances the scope of career opportunities this field offers. Pharma recruitment companies provide ample opportunities for qualified and experienced candidates working in this field.

What are the skills necessary for this job? After completion of a four year university course in specific subjects including medicine, pharmacy, chemistry and biology, an individual needs to complete two years in undertaking qualitative and quantitative analysis of medicines. Qualifications corroborated by certificates and documents are essential when you are applying for jobs in this domain. Experience in similar research work is also an added advantage. The opportunities in this field are increasing with the increase in understanding of the impact of pharmacovigilance on the use of medicines in the healthcare sector.

by: Steven Hayes




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