Drug safety offers a good career option for people who want to explore positions like Drug Safety Associate / Executive / Scientist etc.
Pharmacovigilance professionals play a very vital role in monitoring the safety of drugs that are undergoing clinical trials and also those that are readily available in the market. Pharmacovigilance teams enter safety data in various databases and try to identify any trend in adverse event reports for each product that are reported by consumers and physicians.
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You must have often heard of many drugs being taken off from the market due to identification of new side effects. This is made possible by only pharmacovigilance and thus a career in pharmacovigilance can be very satisfying. By definition, Pharmacovigilance is a pharmacological science, which is related to the assessment, detection, understanding and prevention of adverse effects of medicines. These drug side effects can be long or short term i.e. some side effects may develop soon after using the medicine while others may need a longer exposure to produce any toxic effects. Pharmacovigilance can thus also be defined as a science of monitoring, researching and evaluating adverse effects data on medications, and herbal and biological products collected from health care providers such as doctors, pharmaceutical companies or reported directly by patients. Pharmacovigilance activities start from the clinical development stage of product (drug or medical device) development and they progress throughout the life cycle of the product. Three primary stakeholders of Pharmacovigilance in the United States include the Food and Drug Administration (FDA), The Pharmaceutical Manufacturers and the academic/non-profit organizations such as RADAR and Public Citizen. Research is done on how to identify the potent hazards and risks that are associated with the use of medicinal drugs. The overall goal is to prevent patients from the harm that can be caused due to side effects of medicines. Pharmacovigilance and drug safety are significant functions throughout the development, marketing and in continued use of any medicinal drug and device. Professionals in this role such as Drug Safety Associates are responsible for monitoring, processing, controlling and reporting the adverse event data which is obtained from clinical trials and other sources.
Some common responsibilities of Drug Safety Associates and Pharmacovigilance professionals in general are:
– Documentation of all communication from clinical trial sites such as telephone conversations, faxes etc
– Accurate and timely reporting of side effects
– Processing of collected data in company databases as per applicable standards, regulations and guidelines
– Ensure data accuracy and consistency
– Meet project milestones and timelines
– Understanding, developing, and communicating pharmacovigilance project budgets
– Participate in client meetings and contribute to the discussion from a pharmacovigilance point of view
Competencies & Skills:
Various competencies and skills are required to make a career in pharmacovigilance. Some of them are:
– Thorough understanding of adverse event reporting and safety databases
– Excellent interpersonal and communication skills
– Good time management and organisational skills
– Multi-tasking ability
– Ability to work under pressure
– Understanding of ICH GCP and drug development process
– Master’s or Bachelor’s degree preferably in Life Sciences or Pharmacy
– Extensive knowledge of all applicable guidelines and regulations
For a career in the pharmacovigilance department in any position we suggest you consider the following online program(s):
"I enjoy being a student at JLI. The audio video lectures, online tests, discussion portals and prompt support make JLI a great choice for online learning"
Henry De’souza, MD