Associate Medical Director, Device Safety
4 weeks ago
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 Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
I ndependently responsible for the proactive safety strategy and medical safety aspects of one or more medical device s including medical risk management, signal detection, development of marketed products and safety oversight of clinical studies. Will w ork in close collaboration with cross-functional teams and counterparts in regulatory, clinical development, manufacturing, quality, product support, and other functional areas to identify, evaluate, and communicate safety issues.
Responsibilities:
* Understanding and application of device design, risk and clinical effects and safety to effectively conduct safety surveillance
* Safety surveillance for device/drug -device combination products/IVDs/Digital Health Tools
* Contribute to the authorship of key device safety documents, including but not limited to, medical safety assessments, regulatory responses, and risk management documents
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