Global Lead, Medical Vigilance & Adverse Event Reporting

Medline Industries, Inc.; Northfield (MN); On-site; USD 154,000 - 231,000; Full time

Benefits offered by this job

Health benefits

Life and disability

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a senior leader to manage medical device vigilance and pharmacovigilance activities globally. You will oversee clinical evaluation, medical event management, case processing, coding, and regulatory reporting to ensure safety and compliance across products.

The role requires experience with MedDRA/IMDRF coding, ICSR processing, and cross-functional collaboration with quality and regulatory teams. Travel for audits/inspections may be required.

Qualifications

• Bachelor's degree with a scientific, clinical, nursing, pharmacy, life sciences, or related technical background.
• RN, PharmD/RPh or other healthcare credential preferred.
• At least 5 years of experience in medical device and pharmaceutical Quality Management Systems, including complaint management, regulatory reporting, pharmacovigilance, drug safety, adverse event management, or related Quality/Patient Safety activities.
• At least 2 years of experience managing people, including hiring, developing, motivating, and directing people as they work.
• Experience with FDA medical device and/or pharmaceutical postmarket reporting requirements.

Responsibilities

• Manage Medline's Medical Device Vigilance program and personnel responsible for clinical evaluation and medical event complaint management, reportability assessment, regulatory reporting, follow-up, and event coding.
• Provide management oversight for timely and compliant evaluation of potentially reportable medical device events, and reporting under applicable global requirements.
• Manage Medline's adverse event and pharmacovigilance activities for drugs, biologics, combination products, and applicable consumer products, including adverse event case management, assessment, follow-up, documentation, coding, reconciliation, and regulatory reporting.
• Provide oversight of Individual Case Safety Report (ICSR), Adverse Drug Reaction (ADR), periodic safety reporting, and applicable postmarketing safety reporting activities, including case quality, completeness, regulatory assessment, submission readiness, and regulatory reporting compliance.
• Manage safety coding activities using MedDRA/IMDRF terminologies and ensure medically relevant and consistent coding of adverse events and associated clinical information.
• Oversee adverse event reconciliation activities across applicable functions to support complete and compliant safety data exchange.
• Oversee complaint risk assessments and appropriate escalation for further evaluation through established Quality and Post-Market Risk Management processes.
• Monitor adverse event and medical-event information for potential safety signals and ensure appropriate escalation for additional assessment.
• Work with international and cross-functional partners to ensure adequate assessment, reporting, and continuous improvement of Medline's medical device vigilance and drug/combination product safety activities to meet global needs and changing regulations.
• Stay current with applicable global regulations, guidance, and standards related to medical device vigilance, medical device reporting, pharmacovigilance, drug/biologic adverse event reporting, combination-product reporting, and consumer product safety reporting.
• Provide global support for FDA, Notified Body, MDSAP, and other applicable regulatory inspections and audits.
• Provide training and coaching to personnel globally on adverse event identification and reporting, device vigilance, pharmacovigilance, and related compliance requirements.
• Identify process, procedure, system, and training improvements.
• Typically manages through multiple Managers and/or Supervisors; Oversee major projects/programs/outcomes; Budget responsibility; Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates.

Skills

Medical device vigilance

Pharmacovigilance

Adverse event management

ICSR processing

Regulatory reporting

Safety coding

Cross-functional leadership

Audit readiness

Education

Bachelor's degree in science/related field

RN/PharmD preferred

Tools

MedDRA/IMDRF coding

Microsoft Word

Excel

Job description

Medline Industries, LP is seeking a senior leader to manage medical device vigilance and pharmacovigilance activities globally. You will oversee clinical evaluation, medical event management, case processing, coding, and regulatory reporting to ensure safety and compliance across products.

The role requires experience with MedDRA/IMDRF coding, ICSR processing, and cross-functional collaboration with quality and regulatory teams. Travel for audits/inspections may be required.