Global Head of Medical Event & Pharmacovigilance Compliance

Medline Industries, LP; Mundelein (IL); On-site; USD 154,000 - 231,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a senior leader to oversee medical device vigilance and pharmacovigilance programs across the globe. You will supervise clinical evaluation, AE management, coding, and regulatory reporting to ensure compliant safety data exchange.

The role requires strong cross-functional leadership, experience with FDA postmarket requirements, and a track record of improving safety processes in medical devices and pharmaceuticals.

Qualifications

• Bachelor’s degree with a scientific or clinical background.
• RN, PharmD/RPh or related healthcare credential preferred.
• 5+ years in medical device and pharmaceutical QMS including pharmacovigilance.
• 2+ years managing people and cross-functional teams.

Responsibilities

• Manage Medline’s Medical Device Vigilance program and clinical evaluation.
• Oversee evaluation of potentially reportable medical device events for timely reporting.
• Lead pharmacovigilance activities for drugs and related products, incl. AE case management.
• Oversee ICSR, ADR, PPSR activities and regulatory reporting compliance.
• Coordinate safety coding using MedDRA/IMDRF terminologies.
• Ensure cross-functional escalation and regulatory inspections readiness.
• Drive global safety reporting improvements with international partners.
• Provide training on adverse event reporting and device vigilance.

Skills

Medical Device Vigilance

Pharmacovigilance

Regulatory Reporting

FDA inspections

Team Leadership

MedDRA/IMDRF

ICSR processing

Education

Bachelor’s degree in science/related field

RN or PharmD preferred

Job description

Medline Industries, LP is seeking a senior leader to oversee medical device vigilance and pharmacovigilance programs across the globe. You will supervise clinical evaluation, AE management, coding, and regulatory reporting to ensure compliant safety data exchange.

The role requires strong cross-functional leadership, experience with FDA postmarket requirements, and a track record of improving safety processes in medical devices and pharmaceuticals.