Senior Clinical Safety Analyst

AbbVie

. Independently review safety-related clinical trial data for content, quality, and adherence to regulatory guidance and protocols .

Posted 9/17/2026full-timeRemote • Illinois • United StatesSenior💰 $78,500 - $141,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in reviewing safety-related clinical trial data, analyzing adverse events, and applying ICH, FDA, and EMA regulations. Proficient in developing safety review plans and effectively communicating with cross-functional teams.

Highest-signal resume keywords

Clinical Trial Data ReviewAdverse Event AnalysisDrug Safety ExperienceRegulatory ComplianceEffective Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ExperienceAdverse Event CodingMedical Data EvaluationSafety Report WritingData Interpretation

Soft Skills

Problem SolvingMentoringTask PrioritizationJudgment

Tools & Technologies

WindowsWordExcelOracle/ClinicalPIMSLaboratory Databases

Certifications & Qualifications

Bachelor's Degree in Health ScienceRN or Clinical Pharmacy Experience

Industry Keywords

ICH GuidelinesFDA RegulationsEMA GuidelinesClinical SafetyPharmacovigilance

Tech Stack

Tools & technologies

Oracle

About the role

Key responsibilities & impact

Independently review safety-related clinical trial data for content, quality, and adherence to regulatory guidance and protocols
Collect, analyze, and triage adverse events
Participate in safety surveillance activities for assigned products
Plan and complete ad hoc safety reports
Assess adverse event coding for consistency and accuracy
Medically review safety-related CRFs and laboratory data
Communicate with Study Designated Physicians, study managers, CROs, CRAs, Data Management, Pharmacovigilance, and other stakeholders to resolve queries
Track safety-related queries to investigators and assist with IRB/IEC safety questions
Develop and implement Study Safety Review Plans
Provide safety overviews to clinical teams, CROs, investigators, and investigator sites
Review study protocols, IND reports, annual reports, Investigator Brochures, clinical report safety sections, monitoring plans, IDMC data, and other safety reports
Create narratives for serious adverse events and other events of interest
Apply ICH, FDA, and EMA regulations and guidelines to assigned responsibilities
Understand, implement, and improve department SOPs
Represent Safety Management on cross-functional projects without decision-making responsibility
Prioritize workload, train others, reconcile databases, and conduct safety surveillance
Troubleshoot problems and escalate appropriately to the manager
Mentor and coach designated Safety staff on assigned activities

Requirements

What you’ll need

Bachelor's degree with related health science background is required
RN or clinical pharmacy experience strongly preferred
Candidates lacking the appropriate Bachelor's degree but with previous pharma experience may be additionally considered
Minimum 3 years clinical experience with a minimum of 1 year drug safety/pharma experience, or 2 years clinical experience with a minimum of 3 years drug safety/pharma experience
Proficiency in Windows, Word, Excel, Oracle/Clinical, PIMS, and laboratory databases
Ability to critically evaluate medical data
Ability to accurately and medically present case data orally and in writing
Ability to identify, prioritize, and assign tasks to others in the Clinical Safety Manager's absence
Ability to monitor problems through resolution
Ability to analyze and interpret adverse event data
Ability to exercise good judgment within policies and regulations
Effective communication skills in delivering study-related information

Benefits

Comp & perks

Paid time off (vacation, holidays, sick)
Medical, dental, and vision insurance
401(k)
Short-term incentive programs
Equal opportunity employer
Reasonable accommodations for applicants
Veterans/Disabled applicant support