PV Systems Manager

Location
Dublin (City), Leinster (IE)
Salary
Negotiable
Posted
13 Apr 2021
Closes
13 May 2021
Ref
JO-2103-TD
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

On behalf of my client, a global pharmaceutical company, we are working with them on a new opportunity for a PV Systems Manager.   Based in Dublin this is a permanent vacancy.

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