Location: Chicago,IL, USA
Company Description
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 Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
Purpose: Promotes risk management strategy excellence through the development and application of a structured, iterative, end-to-end lifecycle risk management framework.
Responsibilities:
+ Serve as the subject matter expert on Risk Management Strategy across therapeutic areas, advising and participating in various scientific discussions and activities with internal stakeholders.
+ Advise Product Safety Teams (PST) and relevant AbbVie asset strategy teams on risk management strategies, medication error prevention, and benefit-risk assessments to support product development programs, new marketing applications, and marketed products.
+ Collaborates with the TA leads and PST leadership on early drug development approaches to anticipate and further characterize specific risks for an asset, risks that are common across assets, and drug combination risks.
+ Assess and recommend industry-leading approaches to best quantify, analyze, and mitigate complicated risks and medication errors including the use of digital tools, artificial intelligence, and educational frameworks across products.
+ Partner with the Office of Health Literacy to utilize patient-centric approaches to risk minimization
+ Key advisor on regulatory aspects of RM and monitors external environment. Actively involved in external advocacy relating to RM
+ Drive the development and maintenance of an end-to-end lifecycle risk management framework. This includes education, best practices, and standards for risk management processes and activities.
+ A champion for building and managing risk management literacy across PSEQ.
+ Advise the Product Safety Teams, Safety Review Board, and other stakeholders on risk management regulatory strategy
+ Partner with global regulators and industry groups on risk management approaches, tools, and optimal communication approaches
Qualifications
Basic Qualifications/Experience:
+ Health professional degree (MD, PharmD, RPh, RN or related degree) or masters degree in life sciences or related field.
+ Minimum 10+ years experience in patient safety risk management for pharma or a regulatory agency.
The position can be hired as a Senior Medical Director or Senior Scientific Director based on the candidate's level of experience and education.
Desired Skills/Experience:
+ Trained or experienced in clinical practice
+ Knowledge of risk management regulations, guidelines or equivalent
+ Demonstrated experience in global drug safety risk management planning activities and generating RMPs
+ Ability to lead teams and projects across a wide variety of stakeholders.
+ Demonstrated strength in analytical skills and attention to detail.
+ Demonstrated strength in oral/written communication
+ Excellent mentoring, interpersonal communication (oral, written), negotiation, and influencing skills
+ Aptitude in decision-making and problem-solving in a complex environment while influencing multi-functional teams across disciplines, cultures, third-parties, and geographic locations.
+ Ability to craft compelling business cases and effectively champion new ideas.
+ Ability to effectively frame complex issues for decision-makers, and peers and facilitates lessons learned.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ?
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+ 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?
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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 Companys 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, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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Salary: $195,000 - $371,000