The most efficient method to address a specific situation is solely dependent on the drug in question. It also depends on the indication, the type of population being treated, and the issue that is being considered. The type of method also depends on the fact if the information is missing, the type of risk being considered, potential risks, and if the signal detection, evaluation, or safety demonstration is the main objective of the study—the choice of the method in addressing safety concerns the most appropriate design should be employed—the key methods in pharmacovigilance aid the professionals in considering the design of the whole process.
The entirety of the safety profile of the drugs is based on its safety profile governed by the balance of the risks and benefits. These need to adhere to the strict procedure, which is solely mentored and guided by the pharmacovigilance plan. This plan needs to be updated on a regular basis to ensure that the procedure shall not deviate. This plan holds power in the effectiveness of a drug.