Purpose:
This position supports the Clinical Trial Patient Safety Organization to achieve its mission of evaluating and ensuring the quality of clinical trial patient safety data by consistent and accurate delivery of high-quality relevant and timely data review. Contributes to a culture of process improvement, innovation, and cross-functional teamwork aligning with the company vision and strategies.
Responsibilities:
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.