402639 Technical Associate II (Business Strategy and Performance)

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 inspection-readiness

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.