Senior Medical Director, Benefit Risk Management Medical
Job Description About AbbVie
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
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
Lead cross-functional team to design/build additional risk
minimization measures including user testing/human factors
Develop additional risk minimization implementation
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
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.
Basic: MD, Health-Related Doctorate Degree.
5+ years of experience in pharmaceutical industry; 5+ years of
pharmacovigilance experience and/or clinical development
Significant Work Activities
Continuous sitting for prolonged periods (more than 2
consecutive hours in an 8 hour day)
Keyboard use (greater or equal to 50% of the workday)
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.
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