Drug Safety Associate II

Role: Provide drug safety expertise focusing on safety data quality and SAE documentation for biopharma clinical trials. Responsibilities: process and assess SAEs in Argus, generate queries, write narratives and summaries, perform MedDRA coding, ensure high standards of safety data review, and support safety report submissions. Collaborate with Clinical Development, Data Management, Regulatory Affairs, and other departments to optimize safety data handling. Qualifications: BS/BA in Nursing, Pharmacy, or related with minimum 3-5 years' experience; clinical trial adverse event processing experience preferred. Knowledge of biotech/pharma regulatory frameworks, GxP, and familiarity with Argus database advantageous. Experience in oncology or biotech/pharma industry is preferred. Skills: strong analytical, organizational, and communication skills; ability to manage own workload, work collaboratively, and follow established procedures. High-Value: focus on pharmacovigilance, SAE processing, MedDRA coding, experience in biotech/oncology, and compliance with global safety regulations. Work setup: not specified; likely office-based with collaborative environment.