Adverse Event & Drug Safety Specialist

Fresenius Kabi; Lake Zurich (IL); Vor Ort; USD 110.000 - 115.000; Vollzeit

Benefits dieser Stelle

Bonus plan 6% target

401(k) with company contributions

Health benefits (medical, dental, VIs)

Zusammenfassung

Fresenius Kabi in the United States seeks a Drug Safety Scientist to receive, assess, and report adverse drug events, coordinating with global teams and supporting case intake. The role emphasizes regulatory compliance and high-quality data interpretation.

Applicants should hold a clinical degree with 3+ years in drug safety, and possess strong communication and collaboration skills. Fresenius offers a comprehensive benefits package and a target bonus, reflecting a strong team culture.

Qualifikationen

• Minimum 3 years of drug safety and adverse drug safety reporting experience.
• Holds a current medical/clinical professional degree in good standing (e.g., Pharm D, RPH, RN).
• Experience with FDA regulations, safety guidelines, and SOPs relevant to ADEs.
• Experience with PADER preparation is preferred.
• Ability to gather data from multiple sources to build accurate narratives.

Aufgaben

• Receives, assesses, follows up, and processes adverse drug events per regulations and SOPs.
• Oversees PADER preparation with Global Vigilance and coordinates FDA submissions.
• Collaborates with internal/external teams and stakeholders.
• Performs complex ADE case intake and quality checks for regulatory submission.
• Performs additional tasks as required; adheres to Health, Safety, Environment, and Quality Systems.

Kenntnisse

Safety reporting

Regulatory knowledge

Cross-functional collab

Communication skills

Attention to detail

Problem solving

Data interpretation

Ausbildung

Pharm D

RPH

RN

Tools

Aris Global

Microsoft Office

Jobbeschreibung

Fresenius Kabi in the United States seeks a Drug Safety Scientist to receive, assess, and report adverse drug events, coordinating with global teams and supporting case intake. The role emphasizes regulatory compliance and high-quality data interpretation.

Applicants should hold a clinical degree with 3+ years in drug safety, and possess strong communication and collaboration skills. Fresenius offers a comprehensive benefits package and a target bonus, reflecting a strong team culture.