Clinical Safety Analyst

This position is contributing to worldwide 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.
- Reviews and analyzes safety-related data from clinical trials for content, quality, potential study-level trend identification, and adherence to regulatory guidance and protocols.
- Maintains constant state of audit readiness for study deliverables.
- Monitors 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.
- Reviews study protocols to ensure appropriate safety language.
- Reviews safety sections of clinical study reports and other ad-hoc reports that include safety data.
- Creates narratives of serious adverse events and other identified events of interest.
- Stays current with ICH, FDA, and EMA regulatory guidance affecting safety surveillance.
- May serve on departmental process improvement projects.
- Demonstrates AbbVie “Ways We Work” leadership behaviors.

Qualifications:
- Bachelor’s degree with related health science background; RN or clinical pharmacy experience strongly preferred.
- Minimum 2 years’ experience including at least 2 years of clinical practice and preferred 1-year drug safety experience with clinical trial lifecycle management (pre-clinical to Phase III through launch to market).
- Proficiency with Windows, Word, Excel and databases (e.g., oracle/clinical, PIMS, laboratory databases).
- Ability to critically evaluate medical data and understand clinical course and treatment modalities.
- Effective communication skills delivering study-related information.