Contract Drug Safety Specialist - Argus & SAE Expert

Akkodis; Alameda (CA); On-site; USD 114,616,000 - 143,270,000; Full time

Job summary

Akkodis is seeking a Drug Safety Associate II for a 6-month contract in Alameda, CA. This role focuses on safety data quality and SAE case processing in Argus, supporting regulatory compliance and pharmacovigilance.

You will work with cross-functional teams to ensure timely safety reporting, MedDRA coding, and documentation accuracy, leveraging your biotech/pharma experience and attention to detail.

Qualifications

• 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 the Argus database with narrative writing.
• MedDRA coding of SAEs and AEs and development of coding conventions.
• Maintain high-quality safety data documentation in coordination with the Drug Safety Physician.
• Schedule submissions of expedited safety reports in ARGUS as needed.
• Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Project Management.

Skills

SAE processing

MedDRA coding

Safety data management

Regulatory knowledge

Cross-functional collaboration

Time management

Written/verbal communication

Education

BS/BA in related discipline

MS/MA in related discipline

PhD in related discipline

BS/MS in Nursing/Pharmacy or clinical degree

Tools

Argus safety database

Job description

Akkodis is seeking a Drug Safety Associate II for a 6-month contract in Alameda, CA. This role focuses on safety data quality and SAE case processing in Argus, supporting regulatory compliance and pharmacovigilance.

You will work with cross-functional teams to ensure timely safety reporting, MedDRA coding, and documentation accuracy, leveraging your biotech/pharma experience and attention to detail.