Remote Drug Safety Associate II - Argus & MedDRA Expert

System One; Alameda (CA); Hybrid; USD 41,000 - 69,000; Part time

Benefits offered by this job

Health benefits

Dental

Vision

401(k) plan

Life insurance

Voluntary plans

Job summary

System One is seeking a Drug Safety Associate II for a 6-month contract in Alameda, CA. The role requires 3+ years of Argus experience and strong case processing, coding, and safety data documentation.

The candidate will work remotely within commutable distance of Alameda, with collaboration across safety and clinical teams. PhD or nursing/pharmacy clinical degree with 3–5 years of experience is preferred.

Qualifications

• 3+ years of Argus and end-to-end case processing experience.

Responsibilities

• Provide Drug Safety expertise and ensure quality documentation of safety data, especially SAEs.
• Manage and optimize case processing in Argus, including narrative/ASE writing.
• Code SAEs and AEs using MedDRA and develop coding conventions.
• Review case quality with Drug Safety Physician to ensure sound safety data.
• Schedule safety report submissions in Argus as required.
• Collaborate with Clinical Development, Data Management, Regulatory Affairs, and Project Management.

Skills

Argus

Case processing

MedDRA Coding

Narrative writing

Expedited reporting

QC review

Safety data documentation

Analytical skills

Communication skills

Education

Bachelor's or Master's degree in related discipline

PhD or clinical degree (Nursing/Pharmacy) with 3-5 years clinical experience

Tools

Argus Safety Database

Job description

System One is seeking a Drug Safety Associate II for a 6-month contract in Alameda, CA. The role requires 3+ years of Argus experience and strong case processing, coding, and safety data documentation.

The candidate will work remotely within commutable distance of Alameda, with collaboration across safety and clinical teams. PhD or nursing/pharmacy clinical degree with 3–5 years of experience is preferred.