Supervisor, Medical Events Group
5 days ago
We are seeking a highly skilled Supervisor, Medical Events Group to join our team at Abbott Laboratories. As a key member of our Medical Events Group, you will be responsible for providing direct supervision to individuals in the team, ensuring timely review, proper documentation, and on-time filing of vigilance reports globally.
Key Responsibilities- Supervise personnel who review potentially reportable complaints and file Vigilance Reports to Competent Authorities globally.
- Ensure Vigilance Reports are completed and submitted in a timely manner in accordance with applicable procedures by the Medical Events Group staff.
- Work closely with Customer Service, Complaint Evaluations Group, and Complaints Investigation Group to ensure accurate documentation and timely filing of submissions.
- Provide subject matter expertise, guidance, and training to members of the Medical Events Group, as well as to other functional departments.
- Monitor people and processes with an eye towards resolving issues and improving the efficiency of the medical events reporting process.
- Identify any trends that are found during the medical event process and alert management in a timely manner.
- Perform verification of vigilance reports, as well as verification of data compiled for metrics, risk evaluations, CAPAs, and various other MEG-related activities.
- Support the Reportable Confirmed Malfunction List (RCML) process by running monthly reports and assist the Medical Events Group Section Manager in coordinating the associated cross-functional review activities.
- Bachelor's Degree in Science, Medical (Physician, Nursing, Pharmacy), or equivalent in a technical discipline.
- Minimum 3 years of overall experience working in a quality-related role, or equivalent time in clinical laboratory, medical, or nursing experience.
- Demonstrates initiative, problem-solving, and critical-thinking skills. Strong written and verbal communication skills.
- Knowledge of FDA/International guidelines for drug/device safety reporting requirements.
Abbott Laboratories 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.
We are committed to employee diversity and offer a range of benefits, including career development opportunities, free medical coverage, and an excellent retirement savings plan.
Join us at Abbott Laboratories and be part of a team that is revolutionizing the way people monitor their glucose levels with our new sensing technology.
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