Participates in authoring and reviewing documents related to clinical trial safety, post-marketing safety, regulatory submissions and labeling
Job Summary
Participates in authoring and reviewing documents related to clinical trial safety, post-marketing safety, regulatory submissions and labeling.
Supports and provides oversight to staff involved in monitoring safety during clinical trials, including providing input on study protocols, statistical analysis plans and other clinical study-related documents, and performs data analysis to evaluate safety signals and interpret analysis results.
Manages, executes and follows up on internal audits and official inspections in the good practice (GxP) area in collaboration with business partners and tracks completion of audit corrective action plans.
Matching Summary
Participates in authoring and reviewing documents related to clinical trial safety, post-marketing safety, regulatory submissions and labeling.