Company 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 - 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.
Job DescriptionPurpose
This position reports into the Office of the Office of the Product Safety Team (PST), within Strategic Operations under the Clinical Science organization. . The Clinical Science and Patient Safety organization works collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand and communicate the safety profile of our drugs to protect patients worldwide.
The PST Project Management group (PST PM) plays a critical role in shaping and driving the strategic priorities of Patient Safety through providing exceptional and strategic project management leadership across the PST. The PST is a high-profile high-impact team that leads and owns safety decisions and strategy across the product lifecycle. The PST partners with cross-functional stakeholders across the product lifecycle to devise innovative, safety-driven strategies aimed at optimizing the product benefit-risk profile for patients.
Responsibilities:
- In partnership with PST Lead, shape the PST strategic priorities and drive implementation by applying strong understanding of Therapeutic Area, regulatory requirements, signal management & project management to influence characterization of the compound/product safety & effectiveness profile. This responsibility will be accomplished through building strong and trusted relationship with the PST Lead and core team members.
- In partnership with the PST Lead, manage multiple Product Safety Teams across multiple Therapeutic Areas. This includes meeting planning and facilitation, meeting minutes documentation and post- meeting/general team management activities. Increase meeting productivity and advance decision- making effectively through the application of strong skillsets in strategic thinking, influence, leadership, relationship building, proactive-ness, curiosity and active engagement.
- Proactively utilize experience and knowledge to support the PST Lead in framing safety issues and making decisions. Anticipate possible outcomes of safety issues and provide guidance to the PST Lead so that he/she can be proactively prepared. Systematically analyze the impact of safety decisions and connect the dots across other decisions, discussions and actions across the organization. Communicate perspectives to PST Lead and recommend solutions.
- In partnership with PST Lead, manage escalation of safety issues and decisions to management and Safety Review Board (SRB). Create escalation documentation (e. g. SRB presentations) and help prepare the PST Leads for discussions. Manage the close-out of SRB action items for assigned PSTs.
- Support the PST Lead in strengthening internal partnership/influence and establish role as the company leader of safety issues related to their compounds/products. Identify new opportunities for the PST Lead to build relationships and present thought leadership to peers.
- Support the PST Lead in strengthening external engagement/presence by providing recommendations on channels for expanding external engagement including topic ideas for publications, conferences to present at key industry relationships to develop, etc. Support the creation of content for external engagement activities.
- Drive timely development of key PST deliverables by planning and facilitating productive working sessions to create deliverables; share perspectives; push the thinking to create robust deliverables, suggest improvements, and connect the dots.
- Support inspection /audit readiness activities. Engage in supporting PST-related inspection/audit activities and CAPAs/commitments.
This role can be remote within the US or based at our Lake County Headquarters.
Qualifications- BA/BS (prefer nursing or pharmacy, or healthcare professional)
- Education in biological/medical science or healthcare professional (advanced degree preferred).
- At least 5 years' pharmaceutical experience with a strong understanding of the drug development process. Experience in Pharmacovigilance preferred.
- Ability to work independently, influence stakeholders, and present sound business strategies.
Additional InformationApplicable 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
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https://www.abbvie.com/join-us/reasonable-accommodations.html
