Medical Safety Analyst - Nutrition - Columbus, OH

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Medical Safety Analyst

Working at Abbott

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives.

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Columbus, OH location in the Nutrition Division. In Research & Development, our ambition is providing innovative high-quality products, creating sustainable value, delivering superior user experience, and enhancing health outcomes at all stages of life. 

Primary Functions/Goals/Objectives:

As an individual contributor, with guidance from manager/team, functions to support Medical Safety & Surveillance (MSS) by reviewing, assessing, and summarizing medical complaint information.   Critically assess aggregate safety data communicates findings to internal stakeholders. 

What You’ll Work On

• Responsible for day-to-day medical complaints case processing. 
• Collect, assess, and process medical complaints and adverse events in a timely and compliant manner with applicable regulations
• Conduct medical follow up calls to customers as needed to obtain adverse event and/or complaint details
• Coding complaints using appropriate dictionary; searching and inputting data in electronic complaint database
• Conduct medical safety assessments and risk analyses of medical complaints
• Present medical safety related analyses, reports, and/or assessments orally and/or in writing within the department
• Determine complaint reportability to the competent authority; drive on-time vigilance reporting within regulatory timeframes
• Submit Vigilance documentation to local and/ or Global authorities.
• Understanding of department standard operating procedures (SOPs).
• Comfortable developing training materials when needed and have good presentation skills to provide training to a broad international audience. 
• May write or assist in preparing, completing literature or website searches and data analysis for regulatory documentation. 
• Other duties/projects/support as assigned.

Accountability/Scope:

Financial impact is minimal, based on close supervision, but can result from non-compliance with regulations.  Requires specific direction from area manager or mentor.  Assignments are not self-initiated.  Contacts are within department as well as with cross-functional colleagues. Participates in intradepartmental and interdepartmental (with supervision) team(s), projects, and/or goals.  Workload responsibilities are task-related but have a major impact on the organization's procedural and regulatory compliance, as well as the safety of the product for the end-user.

<