AbbVie Associate Director, Benefit-Risk Management in Lake County, Illinois

Description:

Lead Benefit-Risk and Risk Management activities for assigned therapeutic area / products.

Major Responsibilities:
* 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 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.

Qualifications:

Basic:

  • 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
Schedule: Full-time
Shift: Day
Travel: Yes, 15 % of the Time
Req ID: 1705390

Equal Opportunity Employer Minorities/Women/Veterans/Disabled