Copy of Senior Medical Director, Integrated Medical Quality and Device Safety

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.

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.
  MD, DO, or equivalent medical degree with specialty residency and minimum 2 years of patient management experience required.
• Minimum of 3 to 5 years of experience in drug safety, medical device safety, clinical development, pharmacovigilance, regulatory science, or related functions.
• Strong understanding of global medical device regulations, including FDA, EU MDR, and other international requirements.
• Experience evaluating complex safety signals and contributing to cross-functional risk assessments.
• Excellent written, verbal, and presentation communication skills., Experience with combination products and connected/digital medical devices.
• Experience supporting regulatory inspections and health authority interactions.
• Advanced understanding of risk management, quality systems, and product lifecycle management
  Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

• Salary: $182,000

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