Drug Safety Associate II Job at Exelixis, Alameda, CA

ejE2dXNmWTJHQjhiUk1RZjhTSmh2NC9k
  • 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

Job Tags

Similar Jobs

Meyer Jabara Hotels

Security Job at Meyer Jabara Hotels

 ...Job Title: Security Scope: Maintains safe and secure environment for guests and associates by patrolling and monitoring premises...  ...monitoring and setting building and equipment controls. Maintains hotel's stability & reputation by complying with legal requirements.... 

Kroger-54356a7

Wine Steward Job at Kroger-54356a7

 ...Kroger is seeking a wine department team member for our Irving, TX store. You will assist customers, answer product questions, and recommend wine pairings to enhance the shopping experience. The role focuses on delivering exceptional service in a welcoming environment... 

Cynet Health

Travel Physical Therapist (PT) - $2,435 per week in Arroyo Grande, CA Job at Cynet Health

 ...activities during your day off. Sip through wine country and enjoy beautiful scenery without the need to drive far. Wander the historic downtown filled with locally owned establishments and enjoy the vibrant atmosphere. Finish your shift, head to the beach, and savor the... 

Weill Cornell Medicine

Postdoctoral Position in Metabolism, Diabetes, Obesity and Quantitative Cell Biology Job at Weill Cornell Medicine

 ...physiology. The laboratory combines mouse metabolic physiology, quantitative live-cell imaging, advanced microscopy, molecular and cell biology, and quantitative image analysis. Current Research Directions Several projects are available, including studies of:... 

Powerforce Delivery

1099 Pharmacy Delivery Job at Powerforce Delivery

 ...Job Description Job Description 1099 Independent Pharmacy Delivery Driver Company: Powerforce of Texas Location: West Texas (Routes based out of Abilene, TX area; all routes are out-of-town and back) Job Type: Independent Contractor (1099) Be Your Own Boss...