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Sr Medical Director, Product Safety Lead

4 months ago

North Chicago, United States AbbVie, Inc Full time

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

Serve as Indication Product Safety Lead for one or more products or product indications under the direction of the Therapeutic Area (TA) Lead and Global TA. Ensuring safety of one or more products through the product lifecycle (e.g. surveillance, signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities.

Responsibilities:

* Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
* Responsible for safety surveillance for pharmaceutical / biological / drug -device combined products
* Lead, set the strategy and when appropriate write the key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, 15 day aggregate reports.
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