Analyst, Clinical Safety at AbbVie

AbbVie is seeking a Clinical Safety Analyst to triage incoming SAE information and participate in safety surveillance activities. The role involves identifying and escalating adverse event problems, reviewing safety-related CRFs, and ensuring data completeness for regulatory compliance. Strong understanding of ICH/FDA regulations and product labeling is required.

Requirements

• Bachelor's degree with related health science background preferred, RN or clinical pharmacy experience strongly preferred.
• 2 years clinical experience.
• Competent understanding of ICH/FDA regulations and guidelines affecting drug safety issues.
• Sound understanding of product labeling/literature, including safety profile.
• Computer proficiency (Windows, Word, Excel).