Monday, 30 June 2014

Importance of Pharmacovigilance Course and Training

Pharmacovigilance is a science of studying the effects of medicines, on short terms and long term basis, on the individual males and females. This long existing science has, of late, started gaining momentum amongst the younger generation, who are willing to obtain a recognized qualification and also necessary training in the field.

Basic qualifications for an occupation in any discipline in the pharmaceutical industry will be a bachelor degree or post graduation in medicine, nursing, pharmacy or life sciences. However, holding a Bachelor or Master qualification in Pharmacovigilance will upgrade the career to a great extent, since many of the Pharmacovigilance professionals are expected to shoulder and discharge multiple responsibilities in an accurate, time bound and statute-compliant manner.

The Pharmacovigilance Course will enable you to gain that much of the knowledge and understanding that the industry calls for and it will focus on the steps involved in the manufacture of new drugs, assessment or risks/ hazards involved in consuming the drugs - SUSAR (Serious, Unexpected and Suspected Adverse Reactions), a strategy for obviating such threats, conduct of clinical surveys/ research, report writing, signal detections and the existing regulations, drug safety.

A particular area of Pharmacovigilance will require observation and tracking of the reactions and effects in the course of drug trials/ studies and also the submission of reports to the regulatory authorities. Thereafter, the reports have to be analyzed and reviewed so that the profile of the particular medicinal product/s in question, is monitored.

Another area of Pharmacovigilance will require you, study, assess and gather the required data on the safety of the concerned products. It may involve carrying out medical case reviews. The course will entail you to get the positions as Drug Safety Associate or Coordinator or Scientist or other similar Senior/ Management designations in medical writing or quality assurance in the Pharmacovigilance area. Since these positions demand the highest degree of responsibility and authoritative actions and decisions, a great degree of experience and sharpening the acquired knowledge through Pharmacovigilance training is required.

The openings will be mostly in larger companies in the trade; therefore remunerations package will not be a constraining factor for a right candidate, with a good amount of experience. These larger companies will sponsor CROs i.e. Contract Research Organizations to take care of the study and research right from pre-clinical levels and submit the reports. Though the CRO actually does the field activity, the sponsor company will ultimately be held responsible for the results of the research and trials.

There are technical briefing seminars, Pharmacovigilance training, one week/ two weeks, etc., courses, courses focused on certain countries like Saharan African or francophone African or Arabic or Latin American countries. Many a Pharmacovigilance Course is conducted online also.

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