Drug Safety Scientist

Fresenius Kabi•Lake Zurich, IL

20h•$110,000 - $115,000

About The Position

The Drug Safety Scientist receives, assesses, follows up on, processes, and reports adverse drug events involving company products. The role participates in global data exchange with Fresenius Kabi entities and other Fresenius Kabi USA partners, and collaborates with internal and external teams to facilitate case intake. It also supports regulatory reporting, case quality review, and identification of potential product quality and safety issues. Employees are responsible for complying with company requirements related to Health, Safety, Environment, Energy, and Quality Management Systems, consistent with their roles and responsibilities. The salary range is $110,000–$115,000, based on experience. The position is eligible for a bonus plan with a target of 6% of base salary. Final pay depends on factors including experience, education, knowledge, skills, and abilities. Applicants must be authorized to work for any employer in the United States; Fresenius Kabi cannot sponsor or take over sponsorship of an employment visa now or in the future. Employment is at-will and does not guarantee permanent employment.

Requirements

At least 3 years of drug safety and adverse drug safety reporting experience is preferred.
A current medical or clinical professional degree in good standing is required, such as PharmD, RPh, or RN.
Ability to interpret and apply FDA regulations, global and local safety guidelines, and internal SOPs when assessing and processing adverse drug events, including identifying potential product quality issues.
Ability to gather and evaluate information from multiple medical and regulatory sources to develop accurate, medically sound case narratives.
Ability to analyze safety- and quality-related data to identify potential health risks through signal detection.
Working knowledge of PC-based systems, adverse event safety databases, and Microsoft Office applications.
Strong critical-thinking and problem-solving abilities, with the ability to work independently and manage multiple priorities.
Ability to collaborate across functions and participate in peer review processes.
High attention to detail when performing complex case assessments.
Professionalism and interpersonal effectiveness consistent with company values.
Excellent written and verbal communication skills, including the ability to speak, read, write, and understand English sufficiently to perform essential job functions and independently understand workplace communications in a heavily regulated environment.

Nice To Haves

Clinical or hospital experience.
Experience preparing Periodic Adverse Drug Experience Reports (PADER).
Experience with Aris Global systems.

Responsibilities

Receive, assess, obtain follow-up, and perform case intake for adverse drug events in accordance with global and local regulations and standard operating procedures.
Oversee preparation of Periodic Adverse Drug Experience Reports (PADER) with Global Vigilance and coordinate timely submissions to the FDA with Regulatory Departments.
Collaborate with internal and external teams and stakeholders.
Perform complex adverse drug event case intake and quality checks before submission to regulatory authorities.
Perform additional tasks and responsibilities as required.
Ensure compliance with company documents, programs, and activities relating to Health, Safety, Environment, Energy, and Quality Management Systems, as applicable to the role.