Pharmacovigilance

Pharmacovigilance and Regulatory Affairs – Essential Departments within the Pharmaceutical Industry

Pharmacovigilance and Regulatory Affairs are an essential part of the larger health care industry. This article is all about an overview of Pharmacovigilance and Regulatory Affairs departments and what functions both these departments perform.

Pharmacovigilance

Many organizations seeking to hire Pharmacovigilance professionals will expect the candidates to have about four years’ of clinical research experience and/or two years in drug safety function.  On the other hand, entry level opportunities can vary and it is essential for applicants wanting to work in this area to invest time and effort in finding out more about the organization they desire to work for and also get some form of training in Pharmacovigilance to make up for the lack of work experience.

The primary job responsibilities of Pharmacovigilance professionals are to provide product/drug safety data and documentation. Pharmacovigilance professionals are qualified drug safety specialists.  One particular area of their work includes performing a lot of functional responsibilities like safety trend analysis, maintaining adverse reaction data, keeping global safety databases updated and conducting safety training.

Pharmacovigilance is a pharmacological science that helps us to better evaluate the undesired effects of drugs, report them to the applicable authorities and thus help in ensuring that only safe drugs stay in the market. For that reason it is an extremely important job function.  Pharmacovigilance professionals gather adverse drug reactions and safety data from people who have experienced an adverse effect, healthcare providers like physicians as well as hospitals.

Regulatory Affairs

Regulatory affairs specialists are expected to be extremely passionate regarding the safety and efficiency of drugs and medical devices in the health care industry.   Their interest for the sector must be deeply grounded into their function.  This role demands expertise in a few distinct areas to be able to become successful.

Regulatory affairs specialists must have a wide understanding of legal, scientific and business concerns in order to perform their work effectively.  They must ensure that products are developed within the legal framework and as per recommended guidelines.

Regulatory affairs experts play a significant role in communication between their company and different regulatory bodies such as the FDA, Singapore HSA, EMA etc. Some of the assignments and projects they might be engaged in on a day-to-day basis include studying global regulations, gathering data regarding various products relevant to industry, preparing product labels and coming up with arguments for new drugs/medical devices licences.

Some background in regulatory affairs is also expected of medical affairs professionals. Medical affairs and regulatory affairs are two departments that work very closely with each other. Medical Affairs professionals are engaged in projects such as medical literature production, medical consulting, designing clinical trials, providing medical support to ongoing studies etc.

Health care companies often hire people who have relevant experience in regulatory affairs but experience is not always essential. Many companies hire fresher’s who have gone through relevant training in regulatory affairs and have good understanding of regulatory guidelines provided by various regulatory authorities.

Training Program That Can be Taken to Become a Pharmacovigilance and Regulatory Affairs Professional

http://www.jliedu.com/programs/detail/advanced-pg-diploma-in-pharmacovigilance-regulatory-affairs

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