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AbbVie - North Chicago, IL
posted 2 months ago
About the position
The Clinical Safety Analyst supports the Clinical Trial Patient Safety Organization by evaluating and ensuring the quality of clinical trial patient safety data. This role involves the timely review and analysis of safety-related data, contributing to safety surveillance activities, and maintaining audit readiness for study deliverables. The position emphasizes process improvement, innovation, and teamwork, aligning with AbbVie's mission to deliver innovative medicines and solutions.
Responsibilities
- Provides timely assessment of reported clinical trial data and participates in safety surveillance activities for assigned studies.
- Reviews and analyzes safety-related data from clinical trials for content, quality, and adherence to regulatory guidance.
- Maintains constant state of audit readiness for study deliverables.
- Monitors safety-related queries to Investigators.
- Plans and executes study safety reviews in collaboration with the medical monitor.
- Provides safety overviews to clinical teams, Clinical Research Organizations, Investigators, and investigator sites as needed.
- Participates in the review of study protocols to ensure appropriate safety language.
- Reviews safety sections of clinical study reports and other ad-hoc reports.
- Creates narratives of serious adverse events and other identified events of interest according to accepted standards.
- Stays current with ICH, FDA, and EMA regulatory guidance affecting safety surveillance.
Requirements
- Bachelor's degree with a related health science background.
- 2+ years of clinical practice experience.
- Proficiency in Computers (Windows, Word, Excel) and specific databases (e.g., oracle/clinical, PIMS, laboratory databases).
- Ability to critically evaluate medical data and understand clinical courses and treatment modalities.
- Effective communication skills in delivering study-related information.
Nice-to-haves
- RN or clinical pharmacy experience strongly preferred.
- Drug safety experience with clinical trial life cycle management from pre-clinical to Phase III through launch to market.
Benefits
- 401(k)
- Dental insurance
- Health insurance
- Paid holidays
- Paid time off
- Vision insurance
