About this role
Supports the planning and execution of the safety strategy for immunology assets during the entire lifecycle of the drugLeads development and implementation of an asset safety strategy with support of PST-L or managementSupports in the review and synthesis of scientific safety data for critical regulatory and clinical documents — including IB’s DSURs, PSURs, RMPs CSRs, etc. - ensuring medical accuracy, scientific rigor, and clarity of content across immunology assetsFacilitates scientific connections and interactions, information exchange across assets within the safety teamsPrepares material on competitive intelligence, current disease state, and standard of care for key indications/ disease statesCompiles draft slide presentations for internal and external meetings as requiredInteracts with and influences other cross functional departments (e.g. Clinical Development, Statistics, Regulatory Affairs, Clinical Pharmacology, Medical Affairs), as needed, to ensure the successful development, design and implementation of comprehensive safety assessments to support study participants in immunology studies.Drives process improvement and change management for the Immunology Safety team in conjunction with enterprise-wide and functional area plans.Deep dive in literature search and capable to deliver a strong analysis and summary and proposal for any additional needed safety action
Scientific or clinical degree (e.g. NP/PA, PharmD, MS, PhD, MPH, including combinations)At least 5+ years of pharmaceutical industry experience, preferably in patient safety/ PVKnowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocolsStrategic thinking and capacity of analyzing aggregate data and concludeEffectively present recommendations / opinions in group environment both internally and externallyAbility to work effectively under circumstances of uncertainty and complexity.Proven ability to critically evaluate and interpret complex safety data from clinical trials, supporting informed risk-benefit decision-makingStrong ability to influence individual stakeholders and cross-functional teams in a collaborative environmentMust possess excellent oral and written English communication skills.Work collaboratively and lead cross-functional teamsGood communication and influence skillsGood organization and mastering Microsoft office tools 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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