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Job description
Company Description
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
The Indication Product Safety Team (PST) lead for immunology products, under the direction of the Asset PST Lead will be actively and closely collaborating with the development medical lead, setting the safety strategy for a product in a development or approved indication. Indication PST lead will be responsible to one or more indications and will support safety through the product lifecycle (e.g. surveillance, signal detection, validation and assessment, risks assessment and mitigations strategies, etc…) together with the other members of thesafety team (safety scientists, safety architects, and other cross functional colleagues). The PST lead will also closely collaborate with statistical science, epidemiology, regulatory and clinical development leads as well as medical affairs colleagues to support the asset strategy in the given indication with patient safety expertise.
Indication 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, PSURs, and IB updates.
Responsibilities:
Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams, executive leadership and externally, as needed
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
Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
Understanding of the relevant to the patient safety evaluations pharmacology, and non-clinical toxicology data
Effectively write, review and provide input on technical documents independently
Oversight and responsibility for leading the strategy for periodic reports (DSURs, PSURs, PADERs etc.)
Strong team player, able to adapt and work in a fast-paced environment
Responsible for safety surveillance for pharmaceutical / biological / drug –device combined products
Responsible for implementing risk management strategies for assigned products
Proactively engaging, inspiring, coaching and mentoring team and colleagues
Opportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leader
Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Qualifications
MD / DO with 2+ years of patient management experience required
5+years of patient safety experience in the pharmaceutical industry, including relevant leadership experience
Prior involvement in marketing authorization application submissions or other relevant regulatory interactions
Prior experience in pharmaceuticals’ clinical development
Immunology/Internal medicine experience is strongly preferred
Effectively analyze and guide analysis of clinical data and epidemiological information
Effectively present recommendations / opinions in group environment both internally and externally
Write, review and provide input on technical documents
Work collaboratively and lead cross-functional teams
Ability to lead cross-functional teams in a collaborative environment
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
This job is eligible toparticipatein our long-term incentiveprograms.
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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.
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Worksite address
north chicago, IL, 60086, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.