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Medical Events Supervisor

2 months ago

Alameda, California, United States Abbott Laboratories Full time
About the Role

This is a challenging and rewarding opportunity to join the Abbott Laboratories team as a Medical Events Supervisor. As a key member of the Medical Events Group, you will be responsible for ensuring the timely and accurate reporting of medical events to regulatory authorities.

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.
  • 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 and other functional departments.
  • Monitor processes and identify areas for improvement to enhance the efficiency of the medical events reporting process.
  • Identify trends and alert management in a timely manner.
  • Verify vigilance reports and data compiled for metrics, risk evaluations, CAPAs, and other MEG-related activities.
  • Support the Reportable Confirmed Malfunction List (RCML) process by running monthly reports and coordinating cross-functional review activities.
  • Assist in performance evaluations and administrative duties.
Requirements
  • 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.