Assistant Director, Case Processing Center of Expertise

Lake County, IL, US
Jul 27, 2018
Required Education
Bachelors Degree
Position Type
Full time
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.

Key Responsibilities Include:

  • 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.

  • 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.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled