Drug Safety Scientist

301044 Fresenius Kabi USA, LLC; 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

Job Summary

The Drug Safety Scientist receives, assesses, obtains follow-up, processes, and reports adverse drug events regarding company drug products. Participates in global data exchange with Fresenius Kabi entities and other Fresenius Kabi USA partners. Collaborate with internal and external FK teams to facilitate case intake.

• Salary Range: $110,000-$115,000 based on experience
• Position is eligible to participate in a bonus plan with a target of 6% of the base salary (include only if applicable to the grade level)
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most.

• 401(k) plan with company contributions
• paid vacation
• holiday and personal days
• employee assistance program
• health benefits to include medical, prescription drug, dental and vision coverage

Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.

Responsibilities

Receives, assesses, obtains follow-up, and performs case intake for adverse drug events in accordance with global and local regulations and SOPs.

• Oversees preparation of adverse event Periodic Adverse Drug Experience Reports (PADER) with Global Vigilance and coordinates timely FDA submissions with Regulatory Departments
• Collaborates cross-functionally with internal and external teams and stakeholders
• Performs complex ADE case intake and performs quality check for submission to regulatory authority
• Performs additional tasks and responsibilities as required
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Requirements

• Minimum 3 years of drug safety and adverse drug safety reporting experience preferred
• Holds a current medical/clinical professional degree in good standing required i.e. Pharm D, RPH, RN degree
• Clinical/hospital experience preferred
• Demonstrated ability to interpret and apply FDA regulations, global and local safety guidelines, and internal SOPs to the assessment and processing of adverse drug events, including identification of potential product quality issues
• Experience with preparation of adverse event Periodic Adverse Drug Experience Reports (PADER) is preferred
• Proficiency in gathering and evaluating data from multiple medical and regulatory sources to develop accurate and medically sound case narratives
• Experience with Aris Global systems is a plus
• Dynamic highly motivated professional with the ability to work cross-functionally and collaboratively
• Ability to analyze safety and quality-related data to identify potential health risks (signal detection)
• Working knowledge of PC-based systems, adverse event safety databases, and Microsoft Office applications
• Strong critical thinking and problem-solving abilities; able to work independently while effectively managing multiple priorities
• Ability to collaborate cross-functionally and participate in peer review processes
• Maintains a high level of attention to detail while performing complex case assessments
• Demonstrates professionalism and interpersonal effectiveness consistent with company values
• Excellent written and verbal communication skills required
• The Company's primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at-will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients - and to find answers to the challenges they face. We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the company's global headquarters is in Bad Homburg, Germany.

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