Scientific Director/Senior Scientific Director, Benefit Risk Management-Pharmacovigilance &

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 through the product lifecycle.

Responsibilities:

• Advise Product Safety Team and relevant AbbVie asset strategy teams 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 preparation of a product’s B/R assessment with incorporation of cross-functional perspectives.
• Collaborate with statistical colleagues to develop graphical displays of B/R assessments. 
• In partnership with Safety Statistics, advise on quantitative methods for BR assessments, as appropriate.  
• Advise preparation/updating of RMPs for assigned products; specifically advise on pharmacovigilance plan (in partnership with epidemiology) and on risk minimization plan.
• Prepare precedence analysis, as needed, to help teams determine whether or not additional risk minimization or REMS may be needed for a product. 
• Lead cross-functional team to design/build additional risk minimization measures / REMS including user testing.
• In partnership with Epidemiology, advise on effectiveness evaluations for additional risk minimization measures/programs; apply evaluation outcomes to define corrective measures when needed.
• Advise and support affiliates with development of local RMPs/annexes. 
• Serve as the in-house BRM expert for one or more therapeutic areas, advising and participating in various scientific discussions and activities with internal stakeholders. 
• Prepare and/or review B/R and RM sections in pharmacovigilance deliverables, market authorization submission documents or other regulatory documents.
• 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.
• Stay abreast of professional BRM information and technology through conferences, medical literature and other available training, to augment expertise in the BRM area.  May represent AbbVie at key external meetings.

*Position can be hired as a Scientific Director or a Senior Scientific Director based on the candidate's level of experience and education. 

*This can be a remote position and will not require chosen candidate to relocate. 

 

Qualifications

• Advanced Degree (PhD, PharmD)
• 5+ years of experience in pharmaceutical industry; 5+ years of pharmacovigilance experience and/or clinical development (clinical trials) experience.
• Excellent oral and written English communication skills

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 10 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
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.