Sr. Director, Benefit-Risk Management Position Description
- Lead Benefit-Risk and Risk Management activities for assigned therapeutic area and products.
- Serve as SME/consultant to PST/ADT to advise on benefit-risk (B/R) assessments and risk management (RM) strategies to support 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 legislation 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 inspection readiness activities.
- Update / algin, SOPs/WIs/processes across AbbVie to ensure seamless execution of BRM activities.
- MD or DO required
- 3+ years of experience in pharmaceutical industry; 2-3 years of pharmacovigilance experience
- Clinical development experience highly desirable
- Understanding of current benefit-risk and risk management legislation on a global basis
- Non MD may be considered in the Scientific hierarchy
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.