Sr Mgr Regulatory Compliance - Medical Events, Vigilance & AE Case Reporting

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:

• 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.
• Management responsibilities:

• Typically manages through multiple Managers and/or Supervisors
• Oversee major projects/programs/outcomes.
• Budget responsibility.
• Interpret and execute policies for departments/projects; develop, recommend and implement new policies or modifications to existing policies.
• Provide general guidelines and parameters for staff functioning.
• Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.

MINIMUM JOB REQUIREMENTS:

Education

Bachelor's degree with a scientific, clinical, nursing, pharmacy, life sciences, or related technical background.

Certification / Licensure

RN, PharmD/RPh, or other relevant healthcare professional credential preferred.

Work Experience

• 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 within medical device and/or pharmaceutical environments.
• 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.
• Experience supporting regulatory inspections and audits involving post-market safety, medical device vigilance, or pharmacovigilance.

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