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.
Experience/Qualifications:
- 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 tdunne@thornshaw.com or call Tina at +353 1 2784701 or 087 6811990
Thornshaw Scientific is a division of the CPL group. www.thornshaw.com
