Medline Industries, Inc.
Northfield, MN
Job Summary Responsible for leading and managing medical events, Medical Device Vigilance, and Drug/Combination and Consumer Product Adverse Event activities to assure appropriate evaluation, assessment, regulatory reporting, and global compliance throughout the organization. Provide management oversight of medical device vigilance activities, including clinical evaluation, medical event complaint management; reportability assessment and regulatory reporting; follow-up; and risk assessment. Provide management oversight of drug, biologic, combination product, and consumer product safety activities, and management oversight of applicable pharmacovigilance activities, including adverse event case management, case follow-up; Individual Case Safety Reports (ICSRs), Adverse Drug Reaction (ADR) reporting, periodic safety reporting support and applicable postmarketing safety reporting; MedDRA/IMDRF coding; and safety signal escalation. Job Description MAJOR RESPONSIBILITIES:...