Drug Safety Associate II

Seeking an experience Drug Safety professional with 3+ years of recent expertise in Argus, strong end-to-end case processing, case management, MedDRA Coding, narrative writing, expedited reporting, and QC review experience across clinical and post-marketing safety cases. Collaborate with departments such as Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Project Management to handle safety data appropriately.

Job Title: Drug Safety Associate II
Location: Alameda, CA
Type: 6-month contract (potential to renew and convert to FTE after 6 months)
Compensation: Up to $50/hour (dependent on experience)
Work Model: Remote (MUST be within commutable distance of Alameda)
Hours: 40.0

Overview
Seeking an experience Drug Safety professional with 3+ years of recent expertise in Argus, strong end-to-end case processing, case management, MedDRA Coding, narrative writing, expedited reporting, and QC review experience across clinical and post-marketing safety cases.

Responsibilities

• Provide Drug Safety expertise and ensure quality documentation of safety data, especially serious adverse events (SAEs).
• Manage and optimize case processing in the Argus Safety Database, including query generation, narrative and ASE writing.
• Code SAEs and AEs using MedDRA, developing and revising coding conventions for consistent data categorization.
• Review case quality to ensure sound medical safety data documentation in collaboration with the Drug Safety Physician.
• Schedule safety report submissions in Argus as required.
• Collaborate with departments such as Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Project Management to handle safety data appropriately.
• Perform additional duties as needed.
• Bachelor’s or Master’s degree in related discipline, or PhD, or a clinical degree such as Nursing or Pharmacy with 3-5 years of clinical experience.
• Minimum 3-5 years of industry experience in biotech/pharmaceutical sectors, ideally with oncology.
• Experience with clinical trial and spontaneous adverse event processing.
• Proficiency with Argus safety database preferred.
• Knowledge of pharmaceutical regulatory frameworks and patient safety standards.
• Strong analytical, organizational, and communication skills.
• Ability to work collaboratively and manage own workload effectively.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #568-Clinical