Drug Safety Scientist

Fresenius Kabi USA•Lake Zurich, IL

2d•$110,000 - $115,000

About The Position

The Drug Safety Scientist receives, assesses, obtains follow-up, processes, and reports adverse drug events involving company drug 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. The position supports compliant adverse-event processing under global and local regulations and standard operating procedures, including case quality checks and regulatory submissions. The position requires a current medical or clinical professional degree in good standing, such as PharmD, RPh, or RN. At least three years of drug safety and adverse drug safety reporting experience is preferred. Clinical or hospital experience, PADER preparation experience, and familiarity with Aris Global systems are also preferred. 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. Benefits include a 401(k) plan with company contributions, paid vacation, holidays and personal days, an employee assistance program, medical, prescription drug, dental and vision coverage, life insurance, disability coverage, and a wellness program. Applicants must be authorized to work for any employer in the United States; visa sponsorship is not available now or in the future. Employment is at-will.

Requirements

Hold a current medical or clinical professional degree in good standing, such as PharmD, RPh, or RN.
Demonstrate the 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.
Be proficient in gathering and evaluating data from multiple medical and regulatory sources to develop accurate, medically sound case narratives.
Be able to analyze safety- and quality-related data to identify potential health risks through signal detection.
Have working knowledge of PC-based systems, adverse-event safety databases, and Microsoft Office applications.
Have strong critical-thinking and problem-solving abilities, work independently, and manage multiple priorities effectively.
Be able to collaborate cross-functionally and participate in peer-review processes.
Maintain a high level of attention to detail when performing complex case assessments.
Demonstrate professionalism and interpersonal effectiveness consistent with company values.
Have excellent written and verbal communication skills and be able to speak, read, write, and understand English sufficiently to perform essential functions, including independently understanding workplace communications and materials.

Nice To Haves

At least 3 years of drug safety and adverse drug safety reporting experience.
Clinical or hospital experience.
Experience preparing adverse event 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 SOPs.
Oversee preparation of adverse event Periodic Adverse Drug Experience Reports (PADER) with Global Vigilance and coordinate timely FDA submissions 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 related to Health, Safety, Environment, Energy, and Quality Management Systems, consistent with assigned roles and responsibilities.