Position Summary

Under the direction of the Head of Quality Risk Assessment and Combination Products within Integrated Medical Quality and Device Safety, Global Patient Safety, the Senior Medical Director, serves as a trusted strategic partner, providing medical quality and device safety expertise to cross-enterprise stakeholders. The scope of responsibility spans the entire AbbVie portfolio, with consultation and accountability that may include product complaints, surveillance, quality risk management and device risk management.  The Senior Medical Director is a recognized medical and scientific expert who will work closely with Global Patient Safety (GPS) Therapeutic Area stakeholders to support pipeline enablement and strategic development activities for priority pipeline assets, with responsibility for leading the assessment and management of medical device safety signals, product quality issues, and emerging risks, while providing strategic guidance on benefit-risk evaluations and risk mitigation activities. The role drives proactive identification, interpretation, communication, and mitigation of safety concerns while ensuring alignment with global regulatory requirements and AbbVie's patient safety objectives.

Key Responsibilities

Signal Detection and Risk Assessment

• Perform medical assessment of product complaints, adverse events, and product quality issues to determine potential patient impact, reportability, and need for escalation.
• Lead evaluation of safety signals, adverse event trends, and emerging risks from post-market surveillance, literature, clinical studies, and other data sources.
• Contribute to and review Post-Market Surveillance System (PMSS) and Post-Market Clinical Follow-Up (PMCF) activities, ensuring integration of safety data into ongoing benefit-risk assessments.

Medical Quality and Device Safety & Risk Management

• Provide medical expertise for Quality Risk Management (QRM) activities, including benefit-risk evaluations, risk mitigation plans, and cross-functional risk reviews.
• Serve as a medical safety expert accountable for Health Hazard Assessments (HHA) for quality and device-related issues.
• Provide medical input and oversight for Device Risk Management activities throughout the product lifecycle, ensuring risks are appropriately identified, evaluated, monitored and controlled.
• Author, review, and contribute to regulatory submissions, health authority responses, deficiency responses, and other regulatory communications related to device safety, product quality, and risk management.
• Support internal and external inspections, audits, and health authority interactions by serving as a subject matter expert for medical device safety, vigilance, and risk management activities.

Cross-Functional Partnership

• Support process improvement initiatives, procedural development, and implementation of best practices to enhance device safety, surveillance, and quality-related processes.

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