JOB DETAILS

1)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.
2)Reports that are collected must be organized based on the seriousness or effectiveness of the drug initially.

3)An overall consistency in assessing the adverse reaction reports must be accurate & legible.

4)Must be judgmental in taking appropriate decisions by applying their knowledge of FDA & ICH-GCP standard regulations.

6)Must be able to communicate with clinical physicians in drug safety and assess case report forms.

7)Must be able to distinguish & analyze the ratio of risks & benefits of a drug that is marketed.
FUNCTIONAL AREA
drug safety associate, drug safety, healthcare service provider, drug safety officer jobs in table manufacturing in...