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
Senior Medical Director, Integrated Medical Quality and Device Safety employer: AbbVie Inc
AbbVie is an exceptional employer that prioritises innovation and employee growth, offering a collaborative work culture where engineers can thrive in their roles. Located in Massachusetts, employees benefit from a comprehensive package of benefits, including medical insurance and generous paid time off, while also having the opportunity to engage in meaningful projects that directly impact health outcomes. With a commitment to integrity and community service, AbbVie fosters an environment where every team member can contribute to transformative solutions in healthcare.
