Intellectt INC
Location
Columbus, OH | United States
Job description
As an individual contributor, with guidance from manager/team, functions to support medical safety team by collecting, assessing, processing adverse events for clinical or post-marketed products in compliance with applicable regulations, guidelines, researching, assessing and summarizing nutrition and medical information as well as safety issues concerning foods or products and, by supporting clinical study teams with safety related aspects and issues.
Responsibilities:
Collecting, assessing and processing adverse event information in a compliant and timely manner in order to meet applicable regulatory requirements.
Coding cases using appropriate dictionary, searching and inputting data in electronic databases.
Generating, tracking and resolving adverse event follow-up/distribution correspondence; managing adverse event reports from initial cases and follow-up.
Assisting in the completion of MSS related analyses, reports, and/or projects as assigned, e.g., ingredient and finished product assessments and/or medical safety assessments.
Presenting MSS related analyses, reports, and/or assessments orally and/or in writing within the department.
Researching, organizing and assimilating clinical, safety, and/or toxicology information to support medical safety assessments, clinical study related safety reports, safety fact sheets and chemical approvals.
Assisting in the generation of medical justification content reviews/templates for MSS.
Skills:
0-3 years related experience.
Same industry experience desirable.
Clinical knowledge to apply to adverse event data collection and/or medical/product assessments.
Computer proficient (Windows, Word, Excel) and proficient in specific adverse event databases (as applicable).
Able to present case data, medical and scientific data orally and in writing.
Clinical Monitor or Research Coordinator
Education: Associates or Bachelor's degree preferred in Healthcare or Science. Will consider someone directly out of college.
Interview: In-person
Job tags
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