The Role & Responsibilities:
To manage the PV Systems Team and facilitate system-level functionality of PV databases and related systems (PV systems) including the safety database, product databases and tracking databases. To support data entry to and data extraction from those systems.
• Day to day operational management of all PV Systems Specialists (PVSS) and PV Systems Associates, including:
• Daily workload balancing.
• Training and development.
• Feedback to local HR as requested.
• Contribution to the annual performance management of PVSS and PVSA, including:
• Key performance indicator (KPI) goal setting per company schedule.
• Key performance assessment (KPA) per company schedule.
• Ensuring Team adheres to Good Documentation Practices.
• Delegation of PV systems-related tasks from the QPPV and the Group Executive on an ad hoc basis.
• Overseeing the management of issues relating to data extraction and system-level functionality of PV systems including the safety database, product databases and tracking databases.
• Maintenance of the PV Systems with assistance from the vendor support team and Ireland 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 PV Systems with respect to:
• User access requests.
• Licence utilisation.
• Oversight of PVSS product data workflow management.
• Project management of patches and upgrades to the MPD database system.
• Project management of updates to the Medicinal Product Dictionary (MPD) and the Company Product Dictionary (CPD) including code lists and coding dictionaries.
• Verification of compliance with XEVMPD and IDMP reporting requirements by collection of metrics and overseeing reconciliation with regulator product databases.
• Minimum 5 years’ experience in pharmacovigilance.
• Minimum 2 years’ experience in PV Systems
• Competent in team leadership.
• Competent in medical terminology.
• Strong enterprise application/IT skills.
• Minimum of 2 years’ experience in admin-level operation of a 5th generation safety database or greater (ARISg 5.x, Argus 5.x or a contemporary system)
For full job spec and confidential discussion email your CV to email@example.com or call Zoe at +353 1 2784671 or 087 2972916
Thornshaw Scientific is a division of the CPL group. www.thornshaw.com