AbbVie Associate Director, Benefit-Risk Management in Lake County, Illinois
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 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.
- Work in 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 in 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 relating to BRM processes and activities.
- Anticipate emerging issues and develop solutions relating to BRM processes and deliverables.
- 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.
Advanced Nursing Degree or other Heatlh-Related Advanced Degree.
3 years of experience in pharmaceutical industry; 2-3 years of pharmacovigilance experience
Critical Success Factors:
Understanding of current benefit-risk and risk management legislation on a global basis
Strong interpersonal skills
Strong leadership skills
Job Classification: Experienced
Job: RESEARCH AND DEVELOPMENT
Primary Location: USA-Illinois-Lake County
Organization: Research & Development
Travel: Yes, 15 % of the Time
Req ID: 1705390
Equal Opportunity Employer Minorities/Women/Veterans/Disabled