Clinical Safety Analyst
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Job Description
Clinical Safety Analyst supporting AbbVie’s innovative medicines through clinical-trial safety surveillance. Reviewing safety data, regulatory compliance, and serious adverse-event narratives.
Responsibilities:
- Contribute to worldwide surveillance of clinical trial patient safety data and continuous improvement efforts
- Assess reported clinical trial data in a timely manner
- Participate in safety surveillance activities for assigned studies
- Review and contribute to ad-hoc safety reports
- 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
- Collaborate with the medical monitor to plan and execute study safety reviews
- Provide safety overviews to clinical teams, clinical research organizations, investigators, and investigator sites
- Participate in study protocol reviews to ensure appropriate safety language
- Review safety sections of clinical study reports and other ad-hoc safety-data reports
- Create serious adverse event and other event-of-interest narratives according to accepted standards
- Participate in departmental process improvement projects
- Support AbbVie’s strategic direction through its “Ways We Work” leadership behaviors
Requirements:
- Bachelor's degree with related health science background
- RN or clinical pharmacy experience strongly preferred
- Minimum of 2 years’ experience, including at least 2 years of clinical practice experience
- Preferred 1 year of drug safety experience with clinical trial life cycle management from pre-clinical through Phase III and launch to market
- Proficiency with computers, including Windows, Word, and Excel
- Proficiency with specific databases, such as Oracle/Clinical, PIMS, and laboratory databases
- Ability to critically evaluate medical data, including clinical course and treatment modalities
- Effective communication skills for delivering study-related information
- Current knowledge of ICH, FDA, and EMA regulatory guidance affecting safety surveillance
Benefits:
- Paid time off (vacation, holidays, sick)
- Medical, dental, and vision insurance
- 401(k)
- Short-term incentive programs
- Remote work option
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