Job Reference 14619
Job type Permanent
Location West Dublin
Salary € 40,000-60,000

The Role

  • 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.

The Person

  • Excellent oral and written English communication
  • Detail oriented, solutions provider with the ability to multi-task and work with a high degree of accuracy
  • Above average computer skills
  • Problem solving
  • Service orientation
  • Process driven
  • Honest and trustworthy

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