Ensures oversight of activities and interactions with internal departments and external business partners to:
- Support the International QPPV Office team in meetings, when require
- Set up meetings, prepare agendas and minutes, when required
Provides support to Geographic Expansion activities to:
- Management and implementation of change controls and actions plans for PV activities
- Management of periodic oversight meetings with local QPPVs and PV Partners
- Perform other Geographic Expansion-related activities, as appropriate
Serves as back-up for the PV intelligence Coordinator to:
- Support the maintenance of processes to ensure compliance with worldwide PV regulatory and legal requirements and to address any necessary changes in a timely and appropriate manner
- Assist in identifying actions to be implemented in the marketing authorisation pre-submission phase and following post-marketing authorization approval based on local PV requirements including but not limited to local Pharmacovigilance System Master File (PSMF), local Qualified Person Responsible for Pharmacovigilance (QPPV), local Risk Management Plan/periodic reports. In addition, identify actions to be implemented in marketing authorisation transfer and/or withdrawal
- Support the review of PV agreements, highlighting where local PV requirements should be reflected within the agreements
Serves as the PSMF Administrator/back-up for the PSMFs or equivalent documents to:
- Act as support or back-up for the preparation and ongoing maintenance of the PSMFs or equivalent documents, and the related documentation, in accordance with the assigned schedule
- Help maintain the schedule of updates and data requirements for the PSMFs or equivalent documents
- Ensure the content of the PSMFs, or equivalent documents, are compliant vs GVP Module II requirements by liaising with key contributors from all relevant global functions and/or with the Local applicable PV regulations
Provides support to the International QPPV Office for PV audits and inspections, including:
- Assisting with the readiness, preparation, facilitation and follow-up of PV audits and inspections
- Assisting with the development, management & implementation of corrective & preventative actions (CAPAs) arising from PV audits and inspection