Drug Safety Associate II
Exelixis · Alameda, CA
SafetyFull-time$105k–$148kCompany career page
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Role summary
Exelixis seeks a Drug Safety Associate II to manage serious adverse events and ensure quality safety documentation in the Argus database. The role involves processing SAE cases, MedDRA coding, case quality review, and collaboration across clinical departments to maintain pharmacovigilance compliance.
What they're looking for
- BS/BA in nursing, pharmacy, clinical, or related field plus 5+ years experience
- MS/MA in nursing, pharmacy, clinical, or related field plus 3+ years experience
- PhD in nursing, pharmacy, clinical, or related field
- Biotech/pharmaceutical and oncology experience preferred
- Clinical trial and spontaneous adverse event processing experience
- Argus safety database experience preferred
- Knowledge of regulatory frameworks governing patient safety
What you'll be doing
- Process and assess serious adverse events from receipt through closure in Argus database
- Generate queries, write narratives, and develop adverse event summaries for safety cases
- Apply MedDRA coding conventions to ensure consistent adverse event data categorization
- Conduct case quality reviews to maintain high standards of medical safety documentation
- Collaborate with clinical development, operations, and regulatory departments on safety data handling
Privacy & handoff
This role links to Exelixis's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.