Abbott Sr Medical Safety Analyst in Columbus, Ohio
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
As an individual contributor, independently collects, assesses and processes safety related information (domestic and foreign adverse events for clinical or post-marketed products, formula assessments, etc.) to ensure compliance with applicable regulations and guidelines. Within a specified area, establishes and monitors product safety profiles and/or assists in providing nutrient assessments/recommendations and/or toxicity assessments/expertise to cross-functional project teams. Independently supports clinical study teams with safety related aspects and issues.
Independently collecting, assessing and processing adverse event information in a compliant and timely manner in order to meet applicable regulatory requirements.
Assuming independent responsibility for assigned caseload.
Generating, tracking, and resolving adverse event follow-up/distribution correspondence.
Mentoring/training new MSS staff and assisting others as needed.
Independently completing MSS related analyses, reports, and/or projects as assigned, e.g., product assessments, clinical study related safety reports, medical safety assessments and/or development and monitoring of product safety profiles.
Independently supporting clinical study teams and effectively addressing safety related aspects and issues for clinical studies.
Presenting MSS related analyses, reports, and/or assessments orally and/or in writing within and outside of MSS.
Generating content reviews and medical safety templates to optimize process flow.
Taking the lead in evaluating and generating nutrient specifications during the process of formula development.
Uses IOM and DRIs and other nutrient guideline data to assess product development formulations and specifications.
Organizing metric data for categorical tracking and support of resource allocation decisions.
Supporting MSS strategies
Bachelor's degree with related health science background (Nutrition, Chemistry, or Life Sciences. Master's preferred. At least one year of Toxicology
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com