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Delegation of PV systems-related tasks from the PV Systems Manager (PVSM), EU QPPV and the Group Executive on an ad hoc
Liaising with IT on issues relating to data extraction and system-level functionality of PV systems including the safety database, product databases and tracking databases.
Liaising with PV systems vendors on issues relating to data extraction, systems functionality and user access as well as potential upgrades of those systems.
Liaising with PV Quality Management and Compliance Manager (PV QMCM) to document deviations from SOPs relating to PV Systems and providing assistance with generation and implementation of any resulting CAPAs.
Review and advise on relevant local & global guidelines, policies, internal procedures and SOPs across company affiliate companies.
Database management of the safety database system with assistance from the vendor support team and IT department including:
Project management of patches and upgrades to the safety database system.
Project management of updates to safety database libraries including code lists and coding dictionaries.
Management of user access with regards to safety database and ensuring adherence to number of licences acquired.
Monitoring of support tickets opened with the vendor to minimise redundancy and determine presence of trends or underlying issues.
Coordination of the acquisition and preparation of data in support of Signal Management (SM), product recalls and other surveillance activities.
Support of the Case Workflow Manager in acquisition and preparation of case processing metrics.
Management of outsourced data collection with vendors as required.
Coordination of data migration activities with partner organisations as required.
Coordination of searches from safety, product or regulatory databases.
Provision of support on preparation of reports for review of product quality data, support of health hazard evaluations, scientific presentations etc.
Oversee follow up on data integrity related queries that are raised as a result of reconciliation activities.
Liaise with PVSM, PV QMCM and Quality Assurance (QA) department to ensure all changes to the system is managed via change control.
Coordination of triage, data entry, quality control, medical review and final submission of all product data into MPD with assistance from the Case Workflow Manager and the processing team.
Develop and maintain the company product information (CPD) system with assistance from PV QMCM and ICSR processing team and provide accurate product support.
Excellent oral and written English communication
Detail oriented, solutions provider with the ability to multi-task and work with a high degree of accuracy