What is Pharmacovigilance writing?
Pharmacovigilance medical writing deals with every aspect of drug development starting from clinical trial through, the essential report submission prior to market authorization and then the post marketing phase. Trained writers are required who apply their functional expertise and clinical drug development knowledge to deal with the technical specifications of the document so that the final proof of the document is legitimate and as per the guidelines issued.
The clinical development phase of any drug requires reports on the safety as well as the efficacy of the drug in clinical trials. Reports analyzing safety data form a significant proportion when submitting with respect to marketing authorization. Benefit-Risk regulatory reports is a constant feature for pharmacovigilance medical writers throughout the availability of the product. Pharmacovigilance writers with their analysis of drug safety and efficacy help to bridge the gap between medical health professionals and public thus fostering a sense of trust among patients for medicinal use. In short, these medical writers contribute in clinical drug development by providing their scientific expertise in the development of clinical plan outlines and design of clinical drug development programs for the development of drugs for human use.
Why opt for a career as a Pharmacovigilance writer?
Pharmacovigilance is an integral part of clinical research and is growing globally. Many pharmacovigilance centers are working for drug safety monitoring in this global boom, however, pharmacovigilance systems face major human resource challenges and there is a perennial need for skilled professionals. New drugs take a long time to market and there is a steep regulatory course in which safety forms a vital component for achieving the final goal of marketing authorization.
Pharmacovigilance writers do not only work with Pharmaceutical companies but can find employment with allied industry sectors like contract research organizations, BPO/KPOs, site management organizations, regulatory companies or consultants, government regulatory agencies, etc.
How to make a career in Pharmacovigilance?
James Lind Institute provides intensive training for professionals who would like to opt for the opportunities as pharmacovigilance writers. Pharmaceutical companies are looking for professionals with the scientific expertise to develop reports at various stages of drug development. JLI offers industry accepted online courses which are self-paced and convenient.