This position is contributing to world-wide surveillance of clinical trial patient safety data and continuous improvement efforts.

Core Job Responsibilities include:

• Provides timely assessment of reported clinical trial data and participates in applicable safety surveillance activities for assigned studies including review and contribution to ad-hoc Safety Reports as needed.
• Provide review and analysis of safety-related data from clinical trials for content, quality, potential study level trend identification, and adherence to regulatory guidance and protocols utilizing critical thinking skills.
• Maintains constant state of audit readiness for study deliverables.
• Monitoring of safety-related queries to Investigators.
• In collaboration with medical monitor, plans and executes the plan for study safety review.
• Provides safety overview to the clinical team, Clinical Research Organizations, Investigators and investigator sites as needed.
• Participates in review of study protocols to ensure appropriate safety language.
• Review safety sections of the clinical study reports, and other ad-hoc reports which include safety data.
• Creates narratives of serious adverse events and other identified events of interest in accordance with accepted standards.
• Current with knowledge of ICH, FDA, and EMA regulatory guidance’s affecting safety surveillance.
• May serve on departmental process improvement projects.
• Supports department, division and company's strategic direction by demonstrating the Abbvie “Ways We Work” leadership behaviors.