Lead Medical Safety Specialist

Lake County, IL, US
Oct 12, 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:
  • Collect, assess and process adverse event information (clinical and post marketing) in a compliant and timely manner in order to comply with global regulation which includes.
  • Meeting company standards for quality, compliance and productivity. Remaining current on knowledge and skills required for case processing.
  • Understanding of the changing regulatory environment and the impact to the case management process.
  • Supporting and participating in audits and inspections as needed.
  • Mentoring MSA's in case processing both clinical and post marketing.
  • Leading cross functional teams/projects to deliver results for the organization.
  • Developing cross functional relationships and effectively communicate with internal and external partners.
  • Leading in case quality review.
  • Supporting case processing vendor work and duties including oversight. Supporting ODC activities.
  • Other duties may be assigned based on the need or work requirement of the organization.

  • Minimum: Bachelor's degree with related health sciences background, RN, BSN, BS, BS Pharm. PharmD or advanced degree preferred. Candidates lacking the appropriate degree but with previous pharmaceutical experience may be considered.
  • 4 to 6 years drug safety experience minimum
  • Demonstrated ability to lead project work. Proven success in results-driven process management
  • Core knowledge of industry regulations (ICH, FDA, EMEA, MHRA)
  • Expert in case processing processes, procedures, conventions