Clinical Safety Analyst

Job description

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. Bachelor's degree with related health science background. RN or clinical pharmacy experience strongly preferred. A minimum of 2 years’ experience to include at least 2 years of clinical practice experience and a preferred 1-year drug safety experience with clinical trial life cycle management – Pre-clinical to Phase III through launch to market. Proficiency in Computers (Windows, Word, Excel) and in specific databases (e.g., oracle/clinical, PIMS, laboratory databases). Ability to critically evaluate medical data understanding the clinical course and treatment modalities. Effective communication skills in delivering study-related information.