About this role
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 the safety 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 neededLead 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 componentApply current regulatory guidance as appropriate for safety surveillance and authorship of PV documentsUnderstanding of the relevant to the patient safety evaluations pharmacology, and non-clinical toxicology dataEffectively write, review and provide input on technical documents independentlyOversight 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 environmentResponsible for safety surveillance for pharmaceutical / biological / drug –device combined productsResponsible for implementing risk management strategies for assigned productsProactively engaging, inspiring, coaching and mentoring team and colleaguesOpportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leaderSignificant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) MD / DO with 2+ years of patient management experience required5+ years of patient safety experience in the pharmaceutical industry, including relevant leadership experiencePrior involvement in marketing authorization application submissions or other relevant regulatory interactionsPrior experience in pharmaceuticals’ clinical developmentImmunology/Internal medicine experience is strongly preferredEffectively analyze and guide analysis of clinical data and epidemiological informationEffectively present recommendations / opinions in group environment both internally and externallyWrite, review and provide input on technical documentsWork collaboratively and lead cross-functional teamsAbility to lead cross-functional teams in a collaborative environment 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 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.
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