MEDICAL REVIEWER, MD
• Conduct review and assessment of serious spontaneous reports of adverse events and perform causality assessment of clinical trials and solicited reports
• Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion
• Perform triage on cases and determine seriousness and relatedness across products/sites as assigned
• Acquire and maintain current knowledge of product portfolio and safety profiles for products across DSS therapeutic teams as appropriate
• Escalate complex case issues on team product(s) to the Medical Director of the therapeutic team as appropriate
• Conduct assessment of litigation cases across products/sites as assigned
• Review and provide assurance of medical content and clinical relevance
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