Drug Safety Scientist — ADE Case Expert & PADER Lead

Fresenius Kabi USA; Lake Zurich (IL); On-site; USD 110,000 - 115,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation

Holiday and personal days

Employee assistance program

Health benefits

Job summary

Fresenius Kabi USA seeks a Drug Safety Scientist to receive, assess, follow up, and report adverse drug events for company products. You will collaborate with internal and external teams to facilitate case intake and ensure compliance with global and local regulations. A 3+ year background in drug safety and a PharmD or equivalent are preferred.

The role offers a competitive salary ranging from $110,000 to $115,000, plus a bonus plan (target 6%) and comprehensive benefits. U.S.

Qualifications

• Minimum 3 years of drug safety experience.
• Must hold a clinical degree (PharmD or equivalent).
• Demonstrated ability to interpret FDA regulations and SOPs.
• PADER experience preferred; strong data interpretation skills.
• Ability to collaborate cross-functionally and communicate clearly.

Responsibilities

• Receives, assesses, and processes adverse events per SOPs.
• Oversees ADE case intake and data quality checks.
• Coordinates FDA submissions with Regulatory departments.
• Collaborates with internal and external teams and stakeholders.
• Maintains high attention to detail across complex cases.

Skills

Regulatory interpretation

Cross-functional collaboration

Analytical thinking

Attention to detail

Communication skills

Education

PharmD or equivalent

Tools

ArisGlobal

Microsoft Office

Job description

Fresenius Kabi USA seeks a Drug Safety Scientist to receive, assess, follow up, and report adverse drug events for company products. You will collaborate with internal and external teams to facilitate case intake and ensure compliance with global and local regulations. A 3+ year background in drug safety and a PharmD or equivalent are preferred.

The role offers a competitive salary ranging from $110,000 to $115,000, plus a bonus plan (target 6%) and comprehensive benefits. U.S.