Drug Safety Associate II Job at Exelixis, Alameda, CA

  • Exelixis
  • Alameda, CA

Job Description

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.

Responsibilities

  • 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

Requirements

  • 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

Compensation: $104,500 - $148,000 base annually

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