AbbVie

Associate Director, Clinical Trial Patient Safety

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Jan 13, 2021
Ref
2100239
Required Education
Bachelors Degree
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 .

This position supports the case processing organization to achieve its mission of improving patient lives globally through industry leading safety and compliance by consistent and accurate delivery of high quality, relevant and timely adverse event information.
  • Directs, influences, implements and communicates case processing and reporting policy and direction for Global Product Safety.
  • Evaluates new regulations and guidelines, develops plans and processes for implementation
  • Communicates and coordinates across functional and global boundaries to ensure timely completion of AE cases for regulatory submission.
  • Identifies, evaluates, develops and implements Global Products Safety policies, processes and system improvements.
  • Manages department budgets and projects future financial and resource needs
  • Identifies and anticipates potential department problems impacting the ability to meet regulatory requirements and business goals, develops and implements methods of improvement and resolution.
  • Manages the audit process, prepares responses and develops associated improvement plans (e.g. FDA meetings; responses to warning letters)
  • Works cross-divisionally to influence business processes which impact product safety.
  • Ensures a positive employee relationship, work expectations and employee accountability. Strategically develops responses to employee relationship trends
  • In absence of Associate Director, is responsible for Associate Director duties, including day to day activities.


Qualifications

Basic:
  • Bachelor's degree with related health sciences background, licensed healthcare professional required. RN, BSN, BS, BS Pharm, PharmD or advanced degree preferred. Candidates lacking the appropriate degree but with equivalent previous management or leadership experience may be considered.
  • Minimum 1 year clinical experience
  • 4 years of pharmacovigilance experience required.
  • Global exposure preferred
  • Demonstrated experience in a management capacity required
  • Significant experience leading cross-functional teams on complex projects required.

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)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
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.