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 skillsEqual Opportunity Employer Minorities/Women/Veterans/Disabled