SUMMARY/JOB PURPOSE:

This role is responsible for providing Drug Safety expertise and ensuring the quality documentation of safety data, particularly serious adverse events (SAEs). This role provides support for all major tasks and oversight of outsourced vendors, related to the management and best utilization of case processing activities in the Argus Safety Database, ensuring compliance with global clinical safety and pharmacovigilance regulations and Global Patient Safety department procedures in all aspects of drug safety case processing and reporting.

This role provides support and oversight of all aspects of drug safety study operational activities from study start up to close out.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Technical duties include but are not limited to:

• Processing and assessing SAEs from receipt at Exelixis to case closure in the Argus database, including query generation, narrative, and ASE writ...