Senior Medical Director-Early Oncology Clinical 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
Purpose:
The Product Safety Team (PST) lead for early oncology products, under the direction of the Group Lead and TA Head will be actively and closely collaborating with the development medical lead, setting the strategy for the early oncology programs. The PST lead will also closely collaborate with a PK and toxicology leads to help guide dose selection and regimen, inclusion/exclusion criteria and safety monitoring for first in human and phase I/II studies. The PST lead will be responsible and provide safety oversight (e.g. surveillance, signal detection, validation, and assessment) for early oncology products with a proactive approach to clinical safety, and will be interpreting regulations related to pharmacovigilance to support 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 early oncology 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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