Drug Safety Associate

Job Summary

Providing Drug Safety expertise, the full-time remote Drug Safety Associate will manage the processing and assessment of serious adverse events (SAEs) in the Argus Safety Database, ensuring compliance with global safety regulations and overseeing case processing activities.

Key responsibilities:

• Process and assess SAEs from receipt to case closure, including query generation and narrative writing
• Define and apply quality review standards for medical safety data documentation with support from the Drug Safety Physician
• Collaborate with cross-functional teams to ensure appropriate collection and handling of safety data throughout study operations

Required qualifications:

• BS/BA in Nursing, Pharmacy, or related discipline with a minimum of 7 years of experience; or MS/MA with 5 years; or PhD with no experience; or equivalent combination of education and experience
• Experience in the Biotech/Pharmaceutical industry, preferably in oncology
• Familiarity with the Argus safety database is preferred
• Clinical trial and spontaneous adverse event processing experience
• Knowledge of regulatory frameworks governing patient safety