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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial safety data analysis and regulatory compliance, with a strong background in drug safety and clinical practice. Proficient in evaluating medical data and delivering effective communication to clinical teams and stakeholders.
Highest-signal resume keywords
Clinical Trial Safety Data AnalysisDrug Safety ExperienceRegulatory Compliance KnowledgeEffective Communication SkillsClinical Practice Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data AnalysisClinical Trial ManagementSafety SurveillanceAdverse Event NarrativesProtocol ReviewQuality AssessmentAudit ReadinessMedical Data EvaluationStudy Safety ReviewsProcess Improvement
Soft Skills
CollaborationCritical ThinkingAttention to DetailProblem SolvingInterpersonal Communication
Tools & Technologies
Oracle/ClinicalPIMSWindowsWordExcelLaboratory Databases
Certifications & Qualifications
Bachelor's Degree in Health ScienceRN or Clinical Pharmacy Experience
Industry Keywords
ICH GuidelinesFDA RegulationsEMA RegulationsClinical Trial Life CycleSafety Protocols
Tech Stack
Tools & technologiesOracle
About the role
Key responsibilities & impact- Contribute to worldwide surveillance of clinical trial patient safety data and continuous improvement efforts
- Provide timely assessment of reported clinical trial data and participate in safety surveillance activities for assigned studies
- Review and analyze safety-related clinical trial data for content, quality, study-level trends, and adherence to regulatory guidance and protocols
- Maintain constant 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 reports
- Create narratives of serious adverse events and other events of interest according to accepted standards
- Serve on departmental process improvement projects as needed
- Support AbbVie’s strategic direction by demonstrating its “Ways We Work” leadership behaviors
Requirements
What you’ll need- 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 to Phase III through launch to market
- Proficiency in computers, including Windows, Word, and Excel
- Proficiency in 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
- Current knowledge of ICH, FDA, and EMA regulatory guidance affecting safety surveillance
Benefits
Comp & perks- Equal opportunity employer
- Committed to operating with integrity, driving innovation, transforming lives and serving the community