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Medical Monitor
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- Develops guidelines and ensures the uniform and timely processing of adverse event reports
- Acts as liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
- Performs various tasks in support of clinical research including the reporting, collecting, and sharing of results and issues around adverse event reports both for currently marketed drugs as well as those in the experimental stages of development
- Assists in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communication, product labeling/package inserts, and other reports as necessary
- Maintains/updates agent-specific clinical and preclinical toxicity study summary tables for investigational agents
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