Medical Safety Analyst Nutrition Columbus, OH

Medical Safety Analyst

About Abbott

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. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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 bachelors 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.

Our location in Columbus OH currently has an opportunity for a Medical Safety Analyst - Medical Safety and Surveillance. In Research & Development (R&D) 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 function:

As an individual contributor with guidance from manager/team functions to support ANMSS by collecting assessing and processing domestic and foreign adverse events for post-marketed products (nutritional and drug products) in compliance with applicable regulations and guidelines; researches assesses and summarizes nutrition and medical information as well as safety issues concerning ingredients and/or products.

WHAT YOULL DO

• Collecting assessing and processing adverse event information in a compliant and timely manner in order to meet applicable regulatory requirements and maintain compliance with AN policies and procedures;
• Coding adverse event reports using an 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 medical safety & surveillance related analyses assessments reports (including drug safety related reports e.g. PSUR PBRER) and/or projects as assigned;
• Presenting medical safety & surveillance related analyses reports and/or assessments orally and/or in writing within the department;
• Screening of scientific literature and subsequent management of the safety information identified;
• Performing pharmacovigilance quality checks for individual case safety reports line listings and applicable safety aggregate reports and
• Providing support with the maintenance of metrics related to regulatory submission of adverse events through tracking of reportability requirements

Required Qualifications

• Bachelors degree with related health science background. Masters preferred.
• 1-2 years of clinical and/or other related experience; some industry experience desirable. Higher education may compensate for years of experience.

Preferred

• Basic understanding of relevant domestic and global regulations including drug safety and pharmacovigilance legislations and international standards as well as current clinical practices.
• 1-2 years of experience in pharmacovigilance (drug safety) related role
• Computer proficient (Windows Word Excel) and proficient in specific adverse event databases/ drug safety databases.
• Presents medical and scientific data orally and in writing.
• Healthcare professional (i.e. nurse dietitian pharmacist etc.)

MISC:

• This is an on-site role - not a remote role.
• Sponsorship: we will not provide sponsorship of any kind for this role (including OPT).
• Relocation assistance is not offered for this role.

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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