Pietrek Associates provide safety and risk management services that lead to understanding issues and minimizing the risks.

Key Deliverables

  • Set-up of a new PV system including organizational structure, resource models, process definitions, options for safety database, staff training or optimize the existing one
  • Outsourcing strategies, definition of service specifications, support of selection and qualification of providers
  • Build PV relevant regulatory intelligence
  • Enhance and monitor the quality of ICSRs
  • Perform signal detection, verification and propose signal investigation and/or regulatory actions
  • Implement a safety governance structure for oversight and issue escalation
  • Monitor and evaluate the PV system performance
  • Propose different operational models for a global, regional and/or local PV system and lead the implementation
  • Project management and vendor oversight
  • Assess and improve the ICSR workflow from receipt to reporting and follow-up, collaborate closely with interfacing departments and vendors
  • Generate aggregate reports, risk management plans and risk minimization measures
  • Support the implementation of risk minimization measures
  • Generate/harmonize PV agreements with licensing partners, distributors and service providers

safety risk management