Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management doc
Writing high quality CTD modules nonclinical and clinical overviews & summaries (Module 2.5, 2.4, 2.7, 2.7) Response to clinical deficiencies Clinical study reports, Study design and synopsis Literature search and regulatory evaluation DSUR, PSUR
Performing the Case Analysis and Peer Review (Quality check). Perform medical review (including verifying the coding & labeling reviewing narratives causality statement medical aspect of follow-up request).
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Essential Duties and Responsibilities:
As a Medical Reviewer
* Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports
* Determine regulatory reportability of cases obtain