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

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

• Full-time
• Salary Min: 182000
• Salary Max: 346000
• Workday Global Grade: 22
• Compensation: USD 182,000 - USD 346,000 - yearly

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

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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Required Qualifications

• 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.

Preferred Qualifications

• 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 orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company's sole and absolute discretion, consistent withapplicable 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.

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