Core BSP Accountabilities
Contribute to creation or development of BSP processes and written standards
Collaborate with stakeholders (e.g. PV Operations, the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs), and Clinical Operations/Sciences/Development) to ensure that documentation and processes are in place to achieve successful recording, reporting, analysis and signal detection of safety data during the life cycle of a clinical trial and marketed product
Work across a complex matrix environment to ensure compliance with internal standards and external regulatory requirements
Where process or training issues are identified, facilitate investigation into root cause, creation of corrective/preventative actions (CAPAs), and support with remediation of process/training needs
Review and maintain oversight of BSP training materials
Work with content owners and experts to prepare internal and external presentations as required <...