Global Drug Safety Scientist

Fresenius; Lake Zurich (IL); Presencial; USD 110.000 - 115.000; Tempo integral

Benefícios oferecidos por esta vaga

401(k) with company contributions

Paid vacation, holidays and personal/s

Employee assistance program

Health, dental and vision coverage

Wellness program

Resumo da vaga

Fresenius is seeking a Drug Safety Scientist to receive, assess, follow up on, and report adverse drug events for company products. You will coordinate with Fresenius Kabi USA partners and global teams to facilitate case intake and regulatory submissions.

Salary range is $110,000-$115,000 with a target bonus of 6% and a comprehensive benefits package. Authorization to work in the US is required; visa sponsorship is not available.

Qualificações

• Minimum 3 years of drug safety and adverse drug safety reporting experience preferred.
• Holds a current medical/clinical professional degree (Pharm D, RPH, or RN).
• Clinical/hospital experience preferred.
• Experience with FDA regulations and SOPs in adverse event processing.

Responsabilidades

• Receive, assess, obtain follow-up, and intake adverse drug events per regulations and SOPs.
• Coordinate PADER preparation with Global Vigilance and FDA submissions.
• Collaborate with internal and external teams and stakeholders.
• Perform complex ADE case intake and quality check for regulatory submissions.
• Ensure compliance with Health, Safety, Environment, and Quality Management systems.

Conhecimentos

Excellent written and verbal comms

Strong critical thinking

Cross-functional collaboration

Attention to detail

Formação

Pharm D

RPH

RN degree

Ferramentas

Aris Global systems

Microsoft Office

Adverse event safety databases

PC-based systems

Descrição da vaga

Fresenius is seeking a Drug Safety Scientist to receive, assess, follow up on, and report adverse drug events for company products. You will coordinate with Fresenius Kabi USA partners and global teams to facilitate case intake and regulatory submissions.

Salary range is $110,000-$115,000 with a target bonus of 6% and a comprehensive benefits package. Authorization to work in the US is required; visa sponsorship is not available.