Drug Safety Specialist III — Argus & SAE Expert

Exelixis; Alameda (CA); On-site; USD 131,000 - 185,000; Full time

Benefits offered by this job

401k plan

Medical/Dental/Vision

Life & Disability Insurance

FSAs

Annual bonus program

Stock purchase plan

Long-term incentives

Vacation accrual

Job summary

Exelixis in the United States is seeking a Drug Safety expert responsible for managing SAEs and ensuring high-quality safety documentation in the Argus system. You will lead case processing, MedDRA coding, QA reviews, and coordination with Clinical Development, Regulatory Affairs, and Data Management, with oversight of study operations from start-up to close-out.

The role also includes training staff, scheduling submissions, and contributing to safety study plans, with a comprehensive benefits

Qualifications

• BS/BA or higher in clinical field with minimum 7 years related experience.
• MS/MA in clinical field with minimum 5 years related experience.
• PhD in clinical field with 0+ years related experience.
• Equivalent combination of education and experience.

Responsibilities

• Process and assess SAEs from receipt to case closure in Argus.
• MedDRA coding of SAEs and AEs; develop coding conventions.
• Ensure high standard of case quality review with safety physician support.
• Schedule expedited safety report submissions in ARGUS.
• Train new safety staff on Argus and case processing.
• Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Project Management.
• Perform SAE reconciliation as required by safety management plan.

Skills

Biotech/pharma

Oncology experience

Argus knowledge

SAE processing

Regulatory knowledge

Analytical skills

Time management

Team collaboration

Mentoring

Education

BS/BA in clinical field

MS/MA in clinical field

PhD in clinical field

Equivalent education/experience

Certification in assigned area

Tools

Argus database

Job description

Exelixis in the United States is seeking a Drug Safety expert responsible for managing SAEs and ensuring high-quality safety documentation in the Argus system. You will lead case processing, MedDRA coding, QA reviews, and coordination with Clinical Development, Regulatory Affairs, and Data Management, with oversight of study operations from start-up to close-out.

The role also includes training staff, scheduling submissions, and contributing to safety study plans, with a comprehensive benefits