Clinical Safety Analyst
Posted 12mins ago
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Job Description
Clinical Safety Analyst supporting AbbVie’s global clinical-trial safety surveillance for innovative medicines. Reviewing safety data, regulatory compliance, study reports, and adverse-event narratives.
Responsibilities:
- Contribute to worldwide surveillance of clinical trial patient safety data and continuous improvement efforts
- Assess reported clinical trial data and participate in safety surveillance activities for assigned studies
- Review and analyze clinical-trial safety data for content, quality, study-level trends, and adherence to regulatory guidance and protocols
- Maintain audit readiness for study deliverables
- Monitor safety-related queries to investigators
- Plan and execute study safety reviews in collaboration with the medical monitor
- Provide safety overviews to clinical teams, CROs, investigators, and investigator sites
- Participate in reviewing study protocols for appropriate safety language
- Review safety sections of clinical study reports and ad-hoc safety reports
- Create narratives of serious adverse events and other events of interest
- Support departmental process-improvement projects and AbbVie’s strategic direction
Requirements:
- Bachelor's degree with related health science background
- RN or clinical pharmacy experience strongly preferred
- A minimum of 2 years’ experience, including at least 2 years of clinical practice experience
- Preferred 1-year drug safety experience with clinical trial life cycle management from pre-clinical to Phase III through launch to market
- Proficiency in Windows, Word, Excel, and specific databases such as Oracle/Clinical, PIMS, and laboratory databases
- Ability to critically evaluate medical data, understanding clinical course and treatment modalities
- Effective communication skills in delivering study-related information









