Drug Safety Associate II Job at Exelixis, Alameda, CA

b3ZmanZNNFNabXEwcG9JbXN3NktQdGgv
  • 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

Batteries Plus - LIION Power Inc

Phone Repair Technician Batteries Plus Huntsville Job at Batteries Plus - LIION Power Inc

 ...50 an hour plus commission on every screen and battery device repair. Tech also receives regular Batteries Plus Commission on Key Fob...  ...Plus Bulbs is looking for a person that is able to repair cell phones, tablets, light fixtures, and other devices as needed. As well... 

PruittHealth

Certified Nursing Assistant CNA Private Duty Job at PruittHealth

 ...CERTIFIED NURSING ASSISTANT (CNA) - FAMILY FIRST SERVICES, PRIVATE DUTY Johns Creek, GA: Every day available, 7:00 AM - 3:00 PM JOB PURPOSE: As part of PruittHealths (PH) top initiatives, a new division of Personal Care Services (PCS), PH Family First, is being... 

Maxx Fitness Clubs

Group Fitness and Hot Yoga Instructor Job at Maxx Fitness Clubs

Maxx Fitness 365 Studios is looking for Dynamic High Energy Certified Instructors in Hot Yoga, Barre and Spin among others.If you are looking to share a passion for fitness, then this is the perfect place for you!Essential Duties and Responsibilities:Responsible for providing... 

Midwest Express

Class A Truck Driver Job at Midwest Express

 ...leader in expedited freight and line-haul trucking. With a strong commitment to safety,...  ...neighboring states. As a Class A CDL Truck Driver based in Elk Grove Village, IL, you will...  ...regulations and traffic laws. Maintain accurate logs of working hours and vehicle maintenance... 

Zurich

RCIS Crop Claims Field Adjuster I or Crop Claims Specialist (KS and OK) Job at Zurich

 ...Zurich is currently looking for a RCIS Crop Claims Field Adjuster I or a Crop Claims Specialist to join our Rural Community Insurance Services (RCIS) team. RCIS provides insurance and superior services through leading agents to protect Americas farmers and ranchers....