Drug Safety Scientist

Fresenius Kabi USA

. Receive, assess, obtain follow-up, and process adverse drug events in accordance with global and local regulations and SOPs .

Posted 11/3/2026full-timeLake Zurich • Illinois • United StatesMid-LevelSenior💰 $110,000 - $115,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in adverse drug event reporting and regulatory compliance, with a strong ability to analyze safety data and prepare comprehensive reports. Proficient in collaborating cross-functionally and ensuring adherence to global and local regulations.

Highest-signal resume keywords

Adverse Drug Event ReportingPeriodic Adverse Drug Experience Reports (PADER)FDA Regulations InterpretationData Analysis for Signal DetectionClinical Professional Degree

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Adverse Drug Event Case IntakeQuality Checks for Regulatory SubmissionsData Gathering and EvaluationSafety and Quality Data AnalysisRegulatory Submissions CoordinationMedical Case Narrative DevelopmentCompliance with SOPsAttention to DetailCritical ThinkingProblem-Solving

Soft Skills

CollaborationCommunication SkillsAbility to Manage Multiple PrioritiesIndependent Work

Tools & Technologies

Aris Global SystemsAdverse Event Safety DatabasesMicrosoft Office ApplicationsPC-Based Systems

Certifications & Qualifications

Pharm DRPHRN Degree

Industry Keywords

Drug SafetyHealth and Safety ComplianceQuality Management SystemsGlobal VigilancePeer Review Processes

About the role

Key responsibilities & impact

Receive, assess, obtain follow-up, and process adverse drug events in accordance with global and local regulations and SOPs
Perform case intake for adverse drug events
Oversee preparation of Periodic Adverse Drug Experience Reports (PADER) with Global Vigilance
Coordinate timely FDA submissions with Regulatory Departments
Collaborate cross-functionally with internal and external teams and stakeholders
Perform complex ADE case intake and quality checks for regulatory submissions
Identify potential product quality issues and health risks through safety and quality data analysis
Participate in peer review processes
Ensure compliance with company Health, Safety, Environment, Energy, and Quality Management Systems
Perform additional tasks and responsibilities as required

Requirements

What you’ll need

Minimum 3 years of drug safety and adverse drug safety reporting experience preferred
Current medical/clinical professional degree in good standing required, such as Pharm D, RPH, or RN degree
Clinical/hospital experience preferred
Ability to interpret and apply FDA regulations, global and local safety guidelines, and internal SOPs
Experience preparing adverse event Periodic Adverse Drug Experience Reports (PADER) preferred
Proficiency gathering and evaluating data from multiple medical and regulatory sources to develop accurate, medically sound case narratives
Experience with Aris Global systems is a plus
Ability to analyze safety and quality-related data for signal detection
Working knowledge of PC-based systems, adverse event safety databases, and Microsoft Office applications
Strong critical thinking and problem-solving abilities; ability to work independently and manage multiple priorities
Ability to collaborate cross-functionally and participate in peer review processes
High attention to detail when performing complex case assessments
Excellent written and verbal communication skills
Ability to effectively speak, read, write, and understand English
Must be authorized to work for any employer in the United States; employment visa sponsorship unavailable

Benefits

Comp & perks

Bonus plan with a target of 6% of base salary
401(k) plan with company contributions
Paid vacation, holiday, and personal days
Employee assistance program
Medical, prescription drug, dental, and vision coverage
Life insurance
Disability coverage
Wellness program