2/25/14 – Safety Sytems Analyst

Accentuate Staffing is currently recruiting a Safety Systems Analyst for a client of ours in RTP, NC.

Responsibilities

  • Generate line listings and perform ad hoc queries for GDS
  • Generate data for Annual Periodic Reports and Product Reviews
  • Perform databases searches in support of white papers and medical inquiries
  • Generate regular ad hoc reports; generate and distribute global metrics
  • Perform data reconciliation between clinical and safety databases
  • Provide local application and hardware support
  • Coordinate, integrate, and/or interface with vendor technologies
  • Participate in special projects to drive compliance and efficiency improvements
  • Oversee data migration and work with partners’ systems representatives to coordinate and resolve issues
  • Oversee governance of safety database configuration and coordinate resources accordingly
  • Ensure MedDRA and WHODrug licenses are current, to include: performing contract updates and obtaining financial purchase orders
  • Engage in troubleshooting activities for reports and line listings utilizing solid pharmacovigilance and systems knowledge

Requirements

  • Bachelor’s Degree in Computer Science, Business, Biological Sciences, etc.
  • 8+ years of experience within the Health Care or Life Sciences industry
  • 4+ years of experience in Pharmacovigilance
  • Experience with Safety Databases; Argus is required and ARISg is preferred
  • Ability to work with customers in terms of support, requirement gathering, and training
  • Knowledge of FDA GxP regulation and documentation requirements
  • Proficient in Microsoft Office