Senior Director Benefit-Risk Management

Employer
AbbVie
Location
Lake County, IL, US
Posted
Sep 24, 2018
Ref
1804449
Required Education
Doctorate/PHD/MD
Position Type
Full time
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.

Requirements:

• 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