Senior Drug Safety Scientist

Fresenius Kabi USA

Senior drug safety scientist leading adverse-event processing, FDA reporting, and compliance for Fresenius Kabi’s injectable medicines and clinical nutrition products. Collaborating with global vigilance, quality, and regulatory teams.

Posted 8/10/2026full-timeLake Zurich • Illinois • 🇺🇸 United StatesSenior💰 $133,000 - $146,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in adverse drug event processing, FDA reporting, and regulatory compliance, with a strong focus on collaboration and training within cross-functional teams. Proficient in preparing safety reports and managing Safety Data Exchange Agreements while ensuring adherence to industry regulations and guidelines.

Highest-signal resume keywords

Adverse Drug Event ReportingSafety Data Exchange Agreements ManagementPeriodic Adverse Drug Experience Reports PreparationREMS Operations and ComplianceClinical Judgment and Critical Thinking

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Adverse Drug Event ProcessingFDA ReportingRegulatory ComplianceData AnalysisMedDRA/WHO Drug Coding

Soft Skills

Organizational SkillsTeamworkInterpersonal SkillsLeadership SkillsProfessionalism

Tools & Technologies

KabiSafe LSMV DatabaseMicrosoft Office SuiteLifeSphere MultiVigilanceAris Global Systems

Certifications & Qualifications

PharmDRPhRN

Industry Keywords

Pharmaceutical IndustryPost-Marketing SettingGlobal VigilanceHealth and Safety RegulationsQuality Management Systems

About the role

Key responsibilities & impact

Serve as operational lead for receiving, assessing, obtaining follow-up, processing, and reporting global adverse drug events
Conduct peer review in the KabiSafe LSMV database and Global Complaint Management Workflow for Drug Safety Scientists and Data Specialists
Liaise with the Global Vigilance Medical Manager/PV Physician for medical review and assessment
Act as Subject Matter Expert for adverse drug event processing and FDA reporting
Conduct interdepartmental training on adverse event procedures
Lead planning, development, and maintenance of training materials as needed
Oversee preparation of Periodic Adverse Drug Experience Reports and individual case safety reports
Maintain knowledge of regulations, SOPs, guidelines, product labeling, regulatory safety publications, and company product data
Lead development, implementation, and management of Safety Data Exchange Agreements and perform ADE reconciliation activities as needed
Lead implementation and monitoring of REMS programs as needed
Collaborate with Global Vigilance to identify and resolve case-processing compliance issues
Interact with Quality and Regulatory Departments to resolve safety and quality issues
Assist in creating and revising department procedures and policies
Ensure compliance with Health, Safety, Environment, Energy, and Quality Management Systems
Perform additional tasks and responsibilities as required

Requirements

What you’ll need

Current medical/clinical professional degree in good standing required, such as PharmD, RPh, or RN
Minimum of 8 years of drug safety and adverse drug event reporting experience required
Ability to work cross-functionally and collaboratively
Clinical/hospital experience preferred
Strong organizational, management, teamwork, interpersonal, and professionalism skills required
Adverse drug event reporting experience required
Pharmaceutical industry experience in a post-marketing setting preferred
Experience preparing Periodic Adverse Drug Experience Reports preferred
Experience managing Safety Data Exchange Agreements preferred
Experience with REMS operations and compliance preferred
Excellent clinical judgment and critical thinking skills required
Leadership skills with a focus on solution-based ideas
Initiative and ability to perform duties with minimal supervision
Ability to understand and interpret federal regulations and company operating procedures for medically complex adverse drug events
Ability to determine whether adverse events suggest a product quality issue
Ability to gather data from multiple sources and formulate medically appropriate case narratives
Ability to interpret safety and quality-related data and identify potential health hazards through signal detection
Ability to prioritize and multitask with minimal supervision
Ability to participate in peer review when processing product complaints and adverse drug events
Knowledge of Aris global systems, MedDRA/WHO drug coding, and Microsoft Office Suite (Word, Excel, PowerPoint) required
LifeSphere MultiVigilance experience preferred
Must effectively speak, read, write, and understand English
Must be authorized to work for any employer in the United States
Fresenius Kabi cannot sponsor or take over sponsorship of an employment visa

Benefits

Comp & perks

Bonus plan with a target of 10% 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