Drug Safety Case Specialist — Argus Expert

Connect Life Sciences

San Francisco (CA)

On-site

USD 120,000 - 180,000

Full time

4 days ago

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Job summary

Connect Life Sciences seeks a Drug Safety specialist to provide expertise and ensure quality documentation of safety data, especially serious adverse events. You will manage case processing in Argus Safety, including intake, narrative writing, MedDRA coding, and expedited reporting, while ensuring regulatory compliance across clinical and post-marketing safety activities.

You will coordinate with Clinical Development, Regulatory Affairs, Data Management, and Project Management to maintain high

Qualifications

BS/BA degree in related discipline; 5 years of related industry experience.
MS/MA degree in related discipline; 3 years of related experience.
PhD in related discipline.
BS or MS in Nursing, Pharmacy or other clinical degree with 3–5 years clinical experience.

Responsibilities

Process and assess SAEs from receipt to case closure in the Argus database.
MedDRA coding of SAEs and AEs; develop conventions for consistent data.
Define high-standard case quality review with Drug Safety Physician support.
Schedule submissions of expedited safety reports in ARGUS as needed.
Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Project Management.