Senior Drug Safety Analyst – SAE & Argus Expert

Exelixis

Alameda (CA)

On-site

USD 105,000 - 148,000

Full time

3 days ago

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Benefits offered by this job

401k plan

Medical, dental & vision

Life & disability insurance

Flexible spending accounts

Annual bonus program

Stock purchase plan

Long-term incentives

Vacation & holidays

Job summary

Exelixis is seeking a Drug Safety Specialist to provide pharmacovigilance expertise and ensure high-quality safety documentation for SAEs within the Argus system. This role oversees vendor interactions and ensures compliance with global regulations and internal procedures.

Responsibilities include SAE processing from receipt to closure, MedDRA coding, and quality reviews with the Drug Safety Physician. Collaboration with Clinical Development, Data Management, Regulatory Affairs, and Project

Qualifications

BS/BA in Nursing, Pharmacy, or related clinical discipline with 5+ years of related experience; or MS/MA with 3+ years; or PhD with zero+ years; or equivalent.
May require certification in assigned area.
Experience in Biotech/Pharmaceutical industry and/or oncology preferred.
Clinical trial and spontaneous adverse event processing experience.
Experience using Argus safety database preferred.

Responsibilities

Process and assess SAEs from receipt to case closure in Argus.
MedDRA coding of SAEs and AEs and development of coding conventions.
Defining and applying high standard of case quality review with Drug Safety Physician.
Scheduling submissions of expedited safety reports in ARGUS.
Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, Project Management on safety data handling.
Additional duties as required.