402639 Technical Associate II Business Strategy And Performance
402639 Technical Associate II Business Strategy And Performance
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Job Description
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
Implement changes to Global Safety training curriculums in line with current BSP structure and maintain oversight of BSP training aspects
Manage BSP Optimisation mailboxes for responsible workstream and respond to allocated queries in a timely manner.
Facilitate where required to assess the impact of changes to Pharmacovigilance regulations and track implementation of changes required
Track and oversee regulatory enquiries sent to BSP ensuring appropriate thorough and timely responses
Support with archiving in line with Global Archiving processes ensuring the successful retrieval of documentation and supporting inspectionreadiness
Where problems or issues are identified escalate to BSP Manager / Director as appropriate
Generate new ideas and proposals for global implementation; contribute to advancement of BSP methodology and optimization of processes.
Coordinate BSP involvement in audits and inspections.
Remote Work :
No
Employment Type
Full Time
