Director, Risk Management Strategy, Office of Risk Management, Global Patient Safety

Role Summary

Director, Risk Management Strategy, Office of Risk Management, Global Patient Safety. 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, 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 risk management and monitors external environment.
• Collaborates on the development and maintenance of an end-to-end lifecycle risk management framework, including education, best practices, and standards for risk management processes and activities.
• Collaborates on building and managing risk management literacy across Global Patient Safety.
• Advise the PSTs and other internal stakeholders on risk management regulatory strategy.

Qualifications

• Health professional degree (MD, PharmD, RPh, RN or related degree) or master‚Äôs degree in life sciences or related field.
• Minimum 5‚Äì10 years experience in patient safety risk management for pharma or a regulatory agency.

Skills

• 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 and/or REMS
• Ability to lead projects across a wide variety of stakeholders
• Analytical skills and attention to detail
• Oral/written communication skills
• Mentoring, interpersonal communication, negotiation, and influencing skills
• Decision-making and problem-solving in a complex environment while influencing multi-functional teams across disciplines, cultures, third-parties, and geographic locations
• Ability to champion new ideas and frame complex issues for decision-makers and peers; facilitate lessons learned