This global speciality pharmaceutical organisation are seeking an experienced Pharmacovigilance Systems Manager to join the PV team based at their offices in Citywest, Dublin. Reporting to the Head of Pharmacovigilance, the PV Systems Manager will manage the PV Systems Team and facilitate system-level functionality of PV databases and related PV systems including the safety database, product databases and tracking databases.
Duties and responsibilities of the PV Systems Manager will include but are not limited to:
Team Leadership & Strategy:
- Delegation of PV systems-related tasks from the QPPV and the Group Executive on an ad hoc basis.
- Leading initiatives with the intention of building more efficient integration between PV systems and systems across all relevant Aspen departments and affiliates.
- 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 KPI goal setting per company schedule and key performance assessment (KPA) per company schedule.
Safety Systems Management:
- Maintenance of the PV Systems with assistance from the vendor support team and IT department including project management of patches and upgrades to the safety database system, and 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, and 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 for review from all PV systems.
To be considered for this position you will have skills and experience in the following:
- BSc and 4+ years' experience in pharmacovigilance.
- 2+ years' experience in PV Systems.
- Competent in team leadership.
- Competent in medical terminology.
- Strong enterprise application/IT skills.
- 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)
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 632 1885 for a confidential discussion.