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PV Scientist

Ref: 9221401

  • €45,000 - €50,000
  • 05 May 2020
  • Dublin (West)
  • Perm

Brightwater has been retained in the search for a PV Scientist to manage the system-level functionality of PV databases and related systems (PV systems) including the safety database, product databases and tracking databases and data extraction from those systems.

General

• Delegation of PV systems-related tasks from the PV Systems Manager (PVSM), EU QPPV and the Group Executive on an ad hoc basis. • 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 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. • Ensuring Good Documentation Practice

Safety Systems Management

• Database management of the safety database system with assistance from the vendor support team and Ireland IT department including: o Project management of patches and upgrades to the safety database system. o 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. • Coordination of the acquisition and preparation of data for review from all PV systems in order to support the generation of external reports including periodic reports (such as PSUR, PADER and PBRER) and Risk Management Plans (RMPs). • Coordination of the acquisition and preparation of data in support of Signal Management (SM), product recalls and other surveillance activities. • Management of outsourced data collection with vendors as required. • Management of safety and product data sharing with affiliates. • 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.

Product Database Management

• Database management of the MPD database system with assistance from the vendor support team and Ireland IT department including: o Project management of patches and upgrades to the MPD database system. o Project management of updates to the Medicinal Product Dictionary (MPD) and the Company Product Dictionary (CPD) including code lists and coding dictionaries. • 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 ICSR processing team. • Verification of compliance with XEVMPD and IDMP reporting requirements by collecting metrics and overseeing reconciliation with regulator product databases. • Develop and maintain the company product information (CPD) system with assistance from PV QMCM and ICSR processing team and provide accurate product support.

Visa Compliance

Due to the urgency of this vacancy, it is not possible for our client at this time to consider anyone without the appropriate work permits, visas or sponsorships already in place. Therefore, we are unable to consider candidates who do not have full authorisation to work in Ireland. Applications submitted without the necessary visa in place will not be considered. To apply for this PV Scientist role, click the “Apply Now” button or for more information, please contact Marc Bentley on 01 662 1000 or email m.bentley@brightwater.ie