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

Job Tags

Similar Jobs

Dairy Queen

Kitchen Cook - Restaurant Crew Member Job at Dairy Queen

 ...- Weimar is looking for a hardworking individual to join our kitchen team as a full time or part time Kitchen Cook in Weimar, TX. As part of the BOH team, you'll be responsible for food preparation that meets or exceeds hospitality and service standards, and must be able... 

Piccadilly-Restaurant

Cashier / Checker Job at Piccadilly-Restaurant

 ...other items,and provides the proper change when required. The Checker/Cashier maintains thechecker/cashier station, thanks guests...  ...Piccadilly with a friendly smile.Maintains proper accounting of credit card and other payment information for verification.Correctly... 

Fox Restaurant Concepts

Sushi Cook Job at Fox Restaurant Concepts

 ...of sushi experience required****Full time and weekend availability needed**Please...  ...and North ItaliaFlexible schedules - Part-time & full-time availableTuition...  ...and you're comfortable working in a fast-paced environmentPrepare food from scratch by following our recipes... 

NORTHSIDE BISTRO & COCKTAILS LLC

host/hostess Job at NORTHSIDE BISTRO & COCKTAILS LLC

Job Description Job Description We are looking for a friendly face to greet our guests and make them feel welcome. Must be great at multi tasking, polite, dress neat, and overall friendly. Knowledge of Open Table tablet is a plus.

Kimbrell's Furniture

Delivery Driver Job at Kimbrell's Furniture

 ...Kimbrell's Furniture - JobID: 100-167293592 [Flex Driver] As a Delivery Driver at Kimbrell's Furniture, you'll: Inspect delivery orders in advance to verify accuracy; Load merchandise carefully and thoughtfully to prevent damages and facilitate quick access; Collaborate...