The Associate Medical Director/ Medical Director (PSSR MD) performs the medical assessment activities related to drug safety pharmacovigilance for the assigned therapeutic area(s). The PSSR MD proactively evaluates safety information from individual cases and cumulative data, identifies and analyzes potential signals, and communicates data-driven conclusions to internal and external stakeholders.
• Perform single case medical assessment, including the determination of seriousness, expectedness/listedness/labeledness, and causality of adverse events in compliance with current regulations, internal and external guidance documents, Standard Operating Procedures, Safety Job Aids, the Argus User Reference Guide and case processing/coding conventions.
• Maintain the timely submission of expedited reports.
• Support the achievement of the Therapeutic Area’s case processing performance timelines. Identify cases that meet SUSAR reporting criteria, prepare the SUSAR narrative, perform risk assessment, initiate the unblinding process (as appropriate), and make the report available for distribution.
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