AbbVie

Group Medical Director, Benefit Risk Management

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Oct 26, 2020
Ref
2005625
Required Education
Doctorate/PHD/MD
Position Type
Full time
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. To manage Senior /Medical Directors, Scientific Directors leading projects / programs as BRM Leads or other roles within the BRM group.

Responsibilities:

  • Understand and apply expertise related to pharmacovigilance, clinical development, benefit-risk assessment, and risk management to effectively decide and oversee BRM activities and deliverables.
  • Advise AST /PST on benefit-risk assessments and risk management (RM) strategies / plans 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/local RM documents for assigned Therapeutic Area(s); specifically advise on pharmacovigilance plan (in partnership with epidemiology) and on risk minimization plan. Review RMPs for qualityness and alignment with current regulations.
  • Oversee BRM Lead on strategies and then design / build/ test/ implement / assess phases of additional risk minimization measures / REMS.
  • Effectively write, review, and provide input on technical documents and regulatory deliverables relating to Benefit Risk Management (BRM).
  • Lead and set strategy for innovative benefit-risk projects such as patient preference studies.
  • Lead BRM publication strategy for assigned Therapeutic Area(s).
  • Advise on inspection readiness activities relating to BRM.
  • Understand 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.
  • Proactively engage, inspire, coach and mentor team and colleagues.
  • Manage Associate Medical Directors, Medical Directors, Senior Medical Directors: performance and talent management, coaching and development.


Qualifications
Basic:
  • MD/DO with 5 - 8 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry
  • Effectively analyze and guide analysis of clinical data and epidemiological information
  • Effectively present recommendations / opinions in group environment both internally and externally
  • Write, review, and provide input on technical documents
  • Work collaboratively and lead cross-functional teams
  • Ability to lead cross-functional teams in a collaborative environment
  • Fluency, both written and oral, in English
  • Evaluate and make independent decisions. Ability to work effectively in the situation of uncertainty and complexity, ability to multitask


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)
Travel
Yes, 10 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
E
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.