Director / Senior Director Benefit-Risk Management
Lead Benefit-Risk and Risk Management activities for assigned therapeutic area / products.
Key Responsibilities Include
• Serve as SME/consultant to PST/ADT to advise on benefit-risk (B/R) assessments and risk management (RM) strategies to supporrt drug development programs, new product marketing applications and marketed products. Work in a collaborative manner to facilitate incorporation of cross-functional perspectives into B/R assessments and RM strategies.
• Work in a collaborative manner with statistical colleagues to develop graphical displays of B/R assessments and advise teams on use of quantitative B/R analysis approaches.
• Support preparation / updating of RMPs for assigned products; support affiliates with development of local RMPs/annexes.
• Understand assigned products' pharmacology and benefit/risk profile; understand precedence analysis and apply to BRM deliverables.
• Prepare and/or review B/R and RM sections in clinical development, pharmacovigilance or regulatory documents.
• Drive buy-in, adoption, and compliance with BRM processes across AbbVie.
• Develop risk minimization measures including user testing/human factors testing.
• Develop global/US implementation strategy for risk minimization programs.
• Develop effectiveness evaluations for a risk minimization measures/programs; apply evaluation outcomes to define corrective measures when needed.
• Workin a collaborative manner with office of QPPV to ensure affiliate compliance with execution of RM strategies.
• Ensure development and maintenance of education and communication materials for BRM processes and activities.
• Evaluate impact of new PV legistlation on BRM activities.
• Participate on pharmacovigilance / cross-functional or external initiatives to develop and implement policies and procedures (aligning with requirements of regulatory authorities, global polices and best practices) relating to BRM.
• Support preparation of publications and educational/communication measures relating to BRM processes and activities.
• Anticipate emerging issues and develop solutions relating to BRM processes and deliverables.
• Ability to collaborate with interanl and external relevant parties and partners.
• Support inspection readiness activities.
• Update / algin, SOPs/WIs/processes across AbbVie to ensure seamless execution of BRM activities. Serve as SME to support development of tools and templates to execute BRM processes.
• MD, PhD, PharmD or DO
• 3+ years of experience in pharmaceutical industry; 2-3 years of pharmacovigilance experience
- Clinical development experience highly desirable
- Non MD may be considered in the Scientific hierarchy
Critical Success Factors:
• Understanding of current benefit-risk and risk management legislation on a global basis
• Strong interpersonal skills
• Strong leadership skills
Equal Opportunity Employer Minorities/Women/Veterans/Disabled