- 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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AbbVie South San Francisco, United States 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 ar ...
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AbbVie South San Francisco, United StatesJob Description · Job DescriptionCompany 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 acr ...
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Sonoma Biotherapeutics South San Francisco, United StatesAbout Sonoma Biotherapeutics: · Sonoma Biotherapeutics is a South San Francisco and Seattle-based company leading the development of adoptive Treg therapies cell for autoimmune and degenerative diseases. Using next-generation genome editing and target-specific cell therapy, Sonom ...
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Sonoma Biotherapeutics South San Francisco, United StatesAbout Sonoma Biotherapeutics: · Sonoma Biotherapeutics is a South San Francisco and Seattle-based company leading the development of adoptive Treg therapies cell for autoimmune and degenerative diseases. Using next-generation genome editing and target-specific cell therapy, Sonom ...
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Research Associate
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Research Associate I
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Principal Scientist, Bioanalytics
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Genentech, Inc South San Francisco, United States Full timeA healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Genentech, ...
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Charles River South San Francisco, United StatesFor 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your backgr ...
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Charles River South San Francisco, United StatesFor 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your backgr ...
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Research Associate II
1 week ago
Charles River South San Francisco, United StatesFor 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your backgr ...
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Research Associate II
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Charles River Laboratories, Inc. South San Francisco, United StatesFor 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your backgr ...
Senior Medical Director-Early Oncology Clinical Safety - South San Francisco, United States - AbbVie, Inc
Description
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 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:
