Associate Medical Director, Medical Quality Assurance

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Medical Quality Assurance Physician plays a critical role in ensuring patient safety and product effectiveness within a pharmaceutical setting. This multifaceted position involves collaboration with the Product Safety Team to author and approve Health Hazard Assessments and Medical Opinions concerning potential product-related issues. The Medical Quality Assurance Physician is essential for maintaining high standards of product quality and safety, protecting patient well-being across all stages of product lifecycles.

Major Responsibilities:

•Design of product life cycle strategy, where key Quality System areas are underpinned by medical knowledge commensurate with the potential risk to patient safety e.g. risk assessment, manufacturing / distribution events, product complaints & product discontinuation

•Support the development and maintenance of device / combination products (e.g.- Design History Files, Risk Management Files , product benefit-risk assessments)

•Support the design of ‘product-use’ risk assessment tools, ensuring that the product risk/benefit profile for HCP/patient usage is appropriate

•Review of significant product changes, including specification changes, ensuring appropriate assessment of the proposed changes on patient safety

•Support the design of robust ‘alert’ and ‘action’ thresholds for product complaints, to enable effective signal monitoring, detection and action

•Review and approval of appropriate product complaints providing medical assessment of the potential risk to patient safety

•Review and approval of appropriate product labelling issues providing medical assessment of the potential risk to patient safety partnership, to support potential produ