This short post is an attempt to cover careers pertaining to Pharmacovigilance. One interested in pursuing this career would come across a term called as “Drug Safety Associate”. So who exactly is a Drug Safety Associate and what are the job responsibilities of such a position holder? The roles and responsibilities of a Drug Safety Associate may vary from company to company, but his/her primary responsibilities will be following up Adverse Events Reports, Preparation of Safety Reports as per the guidelines mentioned by the regulatory authority of that particular country, (for example in India it is Schedule Y), to generate clear, concise and comprehendible CRFs, maintenance of safety databases, coding of diseases, ADRS & medications, reconciliation of SAEs in accordance with specific guidelines, review trial protocol on a periodic basis, generation of PSURs etc.
Ever wondered how the data that is generated during a clinical trial is captured? The system used by most pharmaceuticals and CROs these days is called as an Electronic Data Capture or EDC as we know it. So what basically is an EDC? It is a computerized system which is specifically designed to collect data during clinical trials in an electronic format. This system replaces the traditionally used paper based system.
In the recent past, many events have contributed in misleading the general public about the importance of clinical research. Most people tend to believe that clinical research just makes “guinea pigs” out of people with no importance or benefits to anyone in particular. The inaccuracies in both print and mass media along with speculations has highlighted the “ugly” side of clinical research, without actually informing the public of what exactly has gone wrong and what measures are needed to rectify the problem.