Senior Medical Director, Benefit Risk Management
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
To promote excellence in structured benefit-risk (B/R) assessment and patient-centered risk management (RM) in support of new product submissions and product lifecycle management.
- Advise AST on benefit-risk (B/R) assessments and risk management (RM) strategies to support product development programs, new product marketing applications and marketed products.
- Lead and facilitate incorporation of cross-functional perspectives into B/R assessments and RM strategies.
- Collaborate with statistical colleagues to develop graphical displays of B/R assessments and advise teams on use of quantitative B/R methodology.
- Advise preparation/updating of RMPs for assigned products; specifically advise on pharmacovigilance plan (in partnership with epidemiology) and on risk minimization plan.
- Support affiliates with development of local RMPs/annexes.
- Prepare and/or review B/R and RM sections in pharmacovigilance deliverables, market authorization submission documents or other regulatory documents.
- Lead cross-functional team to design/build additional risk minimization measures including user testing/human factors testing.
- Develop additional risk minimization implementation strategies.
- Develop effectiveness evaluations for additional risk minimization measures/programs; apply evaluation outcomes to define corrective measures when needed.
- Support core/global labeling efforts.
- Drive development and maintenance of education and communication materials for BRM processes and activities.
- Support preparation of publications relating to BRM deliverables and methods
- Support inspection readiness activities relating to BRM.
- Drive initiatives to incorporate patient perspective/patient focus into BRM activities and deliverables.
- Evaluate impact of new PV legislation/policies on BRM activities and drive change to enhance BRM processes.
- 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.
- MD, Health-Related Doctorate Degree.
- 5+ years of experience in pharmaceutical industry; 5+ years of pharmacovigilance experience and/or clinical development experience.
Significant Work Activities
Keyboard use (greater or equal to 50% of the workday)
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 10 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.