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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Purpose
Responsible for supporting Product Safety Leads (PSTLs)or serve as a PSTL under the supervision of the Group Medical Director to translate nonclinical and early clinical safety findings, facilitate benefit-risk decision making and risk mitigation for one or more developmental products and during due diligence activities.
Responsibilities:
•Understand and apply pharmacology, chemistry and non-clinical toxicology to effectively conduct safety assessments
•Contribute to the authorship of key safety documents (such as the Investigator’s Brochure or Development Safety Update Report) for early development assets
•Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
•Analyze and interpret pre-clinical and clinical safety data and communicate the analysis and interpretation to cross-functional teams
• Conduct, summarize and communicate safety assessments in due diligence activities for Immunology
Key Stakeholders:
PST Lead, Search and Evaluation Team, Project Management, Regulatory Affairs, Discovery, Clinical Operations
Qualifications
•MD / DO with 2+ years of residency with patient management experience (required)
• Expertise in translational science and/or early research in immune mechanisms of disease, as demonstrated, for example, through a peer reviewed publication (preferred)
•Effectively analyze pre-clinical and clinical data (required)
•Background in bench or clinical research is a plus
•Effectively write technical documents with direction
•Work collaboratively in a team environment and be self-starting and able to work independently
•Ability to effectively present recommendation / opinions in a group environment
•Fluency, both written and oral, in English
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
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AbbVie’s mission is to discover and deliver innovative medicines 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: i...
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