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Drug Safety Associate

Clinical Research & PharmacovigilancePharmacovigilance

Drug Safety Associate

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.

This field is great choice for people who have an eye for details and who are really good with medical terms and terminologies. It helps a good deal for the potential candidate if he/she is aware of the latest happenings in the pharmaceutical industry all over the world. Educational qualification required will include a degree in Life Sciences, Medicine, Pharmacy, PhD etc. Apart from the ones mentioned, a candidate can greatly benefit if he/she has a specialized degree or training in Pharmacovigilance.

James Linds Institute has advanced courses in Pharmacovigilance which prepare the potential candidates for a career in this exciting field. The course content can be accessed online, is self paced and the curriculum has been designed to fit the ever evolving pharmaceutical industry. For more information on the Institute and the courses, potential students can visit

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