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