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. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and 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. Follow us on LinkedIn to learn more: http://bit.ly/3KdaGJr Fresenius Kabi is aware that scammers may attempt to impersonate our recruiters. While we have limited ability to stop these illegitimate efforts, there are some things you can do to protect yourself and not waste time communicating with an imposter. Check the email address – messages from our recruiters will always come from a company account with the Fresenius-kabi.com domain. We have seen imposters send emails using “Fresenius-kaabi.com” which of course includes an extra “a” in “Kabi.” Check our website to see if the position you were contacted about is actually posted. Be wary if someone asks you for personal information. We do not need your driver’s license, social security number, or bank account information before we have made you a conditional offer of employment. Refuse to pay any upfront fees. Fresenius Kabi never charges you a fee to apply for a job at Fresenius Kabi. We will not send you an invoice for equipment (such as a laptop) that we promise to order and reimburse you for once you start working. If you have any questions at any stage of the process, contact us at [email protected]. Do not use any contact information in an unsolicited email. We look forward to talking to you about joining our team.

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