Fresenius Kabi is a global health care company that specializes in lifesaving medicines and medical 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. We are part of Fresenius SE, a health care group with more than 100 years of experience in pharmaceuticals, medical devices and life sciences. Our employees – more than 30,000 worldwide – develop and deliver injectable pharmaceuticals and infusion systems; blood collection, transfusion and cell technologies; and essential nutrients for parenteral nutrition.
Post : DRUG SAFETY SCIENTIST
Job Summary
Receives, assesses, investigates, 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. Interacts with the Quality and Regulatory Departments to resolve safety and quality issues.
Responsibilities
• Receives, assesses, processes, and investigates adverse drug events in accordance with global and local SOPs, and FDA regulations and guidelines.
• Maintain attention to detail in reviewing, assessing and processing adverse drug events.
• Utilization of critical thinking skills.
• Reviews and assesses the medical literature for adverse drug event case reports. May assist the global Adis Coordinator as required, insuring the alert settings and the literature search profile in the Adis database is up to date.
• Participates in the preparation of adverse event Periodic Adverse Drug Experience Reports (PADER), Periodic Safety Update Reports (PSUR), and expedited case reports.
• Maintains current knowledge of applicable local and global regulations, standard operating procedures, and guidelines. Maintains an in-depth understanding of product knowledge, labeling, and relevant data for company products. Maintains knowledge of all pertinent regulatory safety publications.
• Interacts with the Quality and Regulatory Departments to resolve safety and quality issues.
• Maintains a courteous, cheerful, and cooperative demeanor at all times, with both internal and external customers.
• Additional tasks and responsibilities as required.
Candidate Profile
• Medical/clinical professional degree required i.e., PharmD, RPh, RN degree.
• Minimum 3 years of drug safety and adverse drug event reporting experience required. Pharmaceutical industry experience preferred.
• Experience with preparation of adverse event Periodic Adverse Drug Experience Reports (PADER), or Periodic Safety Update Reports (PSUR) is preferred.
• Clinical/hospital experience preferred.
• Ability to understand and interpret federal regulations and company operating procedures as they apply to medically complex adverse drug events and determine whether the events suggest a product quality issue.
• Ability to gather data from multiple sources and references and formulate a medically-appropriate case narrative.
• Ability to interpret large amounts of safety and quality-related data and recognize/identify potential health hazards (signal detection).
• Must be able to prioritize and multi-task with minimal supervision, and participate in peer-review process when processing product complaints and adverse drug events.
• Knowledge of PC systems and Microsoft Office Suite (Word, Excel) required. Lotus Notes experience preferred.
• Excellent written and verbal communication skills required.=
Additional Information:
Experience : 3 years
Industry Type : Pharma
Education : PharmD, RPh, RN degree
Location : Illinois, USA
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