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.
Job Types: Full-time, Fresher
Job Location: Pan India Basis( Bangalore, Mysore, Chennai, Hyderabad, Mumbai & etc.,)
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