Drug Safety Associate III Job at Exelixis, Alameda, CA

  • Exelixis
  • Alameda, CA

Job Description

Exelixis seeks a Drug Safety Associate III to manage adverse event processing and documentation in the Argus database. The role ensures compliance with pharmacovigilance regulations, supports study operations, and collaborates across clinical departments on safety data management.

Responsibilities

  • Process and assess serious adverse events in Argus database, including query generation and narrative writing
  • Perform MedDRA coding of adverse events and develop coding conventions for data consistency
  • Conduct quality reviews of safety data documentation with Drug Safety Physician support
  • Support study operational activities including protocol review, safety forms development, and SAE reconciliation
  • Train new safety staff on Argus and case processing procedures

Requirements

  • Bachelor's degree in nursing, pharmacy, or clinical discipline with 7+ years related experience
  • Or Master's degree in nursing, pharmacy, or clinical discipline with 5+ years related experience
  • Or PhD in nursing, pharmacy, or clinical discipline
  • Biotech/pharmaceutical industry or oncology experience preferred
  • Argus safety database experience preferred
  • Knowledge of regulatory frameworks governing patient safety
  • Strong written and verbal communication skills

Compensation: $130,500 - $185,000 base annually

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