Drug Safety Associate II: SAE & Argus Specialist

Exelixi; Alameda (CA); On-site; USD 89,000 - 148,000; Full time

Benefits offered by this job

401k plan

Medical coverage

Dental & Vision coverage

Life insurance

Disability insurance

Flexible spending accounts

Discretionary bonus

Job summary

Exelixis is seeking a Drug Safety professional to oversee SAE processing, coding, and high-quality safety documentation within the Argus system. You will collaborate with cross-functional teams to ensure compliant data handling and timely safety reporting.

Ideal candidates bring biotech/pharma experience, oncology exposure, and strong communication skills to manage and document pharmacovigilance activities across studies.

Qualifications

• BS/BA in Nursing or Pharmacy with 5+ years of related experience.
• MS/MA in Nursing or Pharmacy with 3+ years of related experience.
• PhD in Nursing or Pharmacy with zero or more years of related experience.
• Biotech/pharma industry and oncology experience preferred.
• Argus safety database experience preferred.
• Regulatory knowledge of patient safety.

Responsibilities

• Process and assess SAEs from receipt to case closure in Argus.
• MedDRA coding of SAEs and AEs; develop coding conventions.
• Maintain high standard of case quality review for safety data.
• Schedule expedited safety report submissions in Argus.
• Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, Project Management.

Skills

Drug safety expertise

Clinical trial experience

Written communication

Team collaboration

Analytical mindset

Education

BS/BA in Nursing or Pharmacy

MS/MA in Nursing or Pharmacy

PhD in Nursing or Pharmacy

Tools

Argus Safety Database

Job description

Exelixis is seeking a Drug Safety professional to oversee SAE processing, coding, and high-quality safety documentation within the Argus system. You will collaborate with cross-functional teams to ensure compliant data handling and timely safety reporting.

Ideal candidates bring biotech/pharma experience, oncology exposure, and strong communication skills to manage and document pharmacovigilance activities across studies.