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
