No sooner than a drug that is marketed, there is always an urgent requirement to monitor if the drug is safe & competent and not restricted to its use in the clinical trials phase. The ambience or situation may not be the same after the clinical study phase & it may not be effective in reflecting the same outcome in the market as it did in the clinical phase. The study of a drug i.e. its actions & reactions may not be known thoroughly is more probable than that reflected in a large sample or population. Regardless of the pre-clinical studies performed on animals including trials on Homo sapiens may certainly have a minor or major adverse reaction that can only be visible & identified on a larger number of people by the intake of a particular drug. In spite of the strict FDA regulations & guidelines that are followed & revised for a drug to be marketed, the indispensable requirement of a pharmacovigilant team or department is necessary to supervise and monitor once a drug is in the market for human consumption to enhance public-health. Pharmacovigilance or Drug Safety carries great demand in trained man-power for the benefit of the people.
To sum up are a fair few roles & responsibilities of a drug safety associate: Every drug safety associate is an asset to the pharmacovigilance department in operating its day to day activities. The basic authority given to a drug safety associate is to overview the adverse events occurred to be identified and reported. Drug safety associate liaise with most healthcare service providers for safety and efficacy aspects.
However, the major functions or actions of a drug safety associate are as follows:
- Needs to ensure that most of the safety reports that are received from the investigational sites or from the post- marketing sector must be identified & reported in accordance to the ICH-GCP standards & also by the standard operational procedures.
- Reports that are collected must be organized based on the seriousness or effectiveness of the drug initially.
- An overall consistency in assessing the adverse reaction reports must be accurate & legible.
- Must be judgmental in taking appropriate decisions by applying their knowledge of FDA & ICH-GCP standard regulations.
- Must be able to communicate with clinical physicians in drug safety and assess case report forms.
- Must be able to distinguish & analyze the ratio of risks & benefits of a drug that is marketed.