Human Resources

  • location: Northbrook, IL
  • type: Contract
  • salary: $59 - $64 per hour

job description

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Job Title: Training Analysis Resource III

Position Description

  • Responsible for defining standards for PV process related matter and procedure in linne with global PV process strategy.
  • Responsible to define standards for AE intake requirements.
  • Continuously assess processes and identify opportunities to improve efficiency, effectiveness and compliance.
  • Coordinate the implementation of process improvements, manage planned and unplanned deviations and ensure accurate periodic review. Global review of Safety Data Exchange Agreements Assist with setting standards, decision making and maintenance of product specific case handling conventions in consultation with Global Medical Expert and PV Process Regional Management Primary liaison with PV Information Management for Argus system changes to ensure accurate and timely assessment of impact to global PV process Liaison with PV functional teams (Medical Safety, Safety Science) for impact of process changes. Perform impact analysis for global regulatory intelligence results
  • Maintain standards and procedures for identification and management of Product Quality Complians associated with safety information coordination with other PV functions and QA units related to triage, case processing, investigation, reconciliation and reporting.
  • Assist PV Process as SME during audits and inspections
  • Assist with development and maintenance of global standards and processes for Data Assurance for case processing and related activities
  • Act as SME for the development of global training materials for case processing procedures

Position Requirements

  • Minimum MSc in life sciences
  • Minimum of 7 years relevant experience in PV or combined PV/RA/QA and/or clinical development Extensive PV knowledge
  • Strong interpersonal skills and multicultural awareness? able to negotiate and build concensus for plans and priorities and develop effective relationshiops through collaboration
  • Excellent oral and written communication skills in English, with an ability to interact with all levels of personnel.
  • Demonstrated ability to practively predict and resolve complex problems, think strategically and tactically, generate solutions to complex problems and build consensus across global organization. Able to interpret, execute and recommend changes to established policies and programs
  • Leadership, decision making and negotiaton skills Independent worker
  • Strong analytical skills
  • Six Sigma or similar process improvement methodlogy knowledge a plus


  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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