- 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 and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans, NDA/sNDA submission - safety component
-
Senior Medical Director, Late Stage PST
3 weeks ago
AbbVie North Chicago, United StatesCompany DescriptionAbbVie'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 – ...
-
Manager, Safety Data Architect
6 days ago
AbbVie North Chicago, United States PermanentJob Description · This position is part of Safety Data Architect team in Clinical Trial Patient Safety. The PPS organization works collaboratively and strategically with colleagues across the product clinical lifecycle to identify, evaluate, understand and communicate the safety ...
-
Senior Team Leader, Costco/BJ's Wholesale
1 week ago
Abbott Laboratories company North Chicago, United StatesAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
-
Manager, Safety Data Architect
1 week ago
AbbVie North Chicago, United StatesCompany 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 area ...
-
Senior Team Leader, Costco/BJ's Wholesale
1 week ago
Abbott Abbott Park, United StatesAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
-
Senior Team Leader, Costco/BJ's Wholesale
1 week ago
Abbott North Chicago, United StatesAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
-
Senior Team Leader, Costco/BJ's Wholesale
1 week ago
Abbott North Chicago, United StatesAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
-
Senior Team Leader, Costco/BJ's Wholesale
1 week ago
Abbott Green Oaks, United StatesJob Description · Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and bra ...
Senior Medical Director, Late Stage PST - North Chicago, 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
The Product Safety Team (PST) lead for late stage 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 oncology programs.
surveillance, signal detection, validation and assessment, risks assessment and mitigations strategies, tox management, etc...) together with the other members of the safety team (safety scientists, safety architects, safety PM, and other cross functional colleagues).
The PST lead will also closely collaborate with a PK and toxicology leads, regulatory and clinical development leads as well as medical affairs colleagues to help guide dose selection and regimen, inclusion/exclusion criteria and safety monitoring for first for clinical trials as well as PMOS.
PST lead will be interpreting regulations related to pharmacovigilance supporting all patient safety activities, and will be leading the safety components of pre-NDA and NDA/sNDA submissions, regulatory responses, label and label updates, RMPs.
Responsibilities: