PV System Specialist

Primary Job Function:

The position holder ensures compliant roll-out of PV training to all global, regional and local PV personnel through maintaining up to date the PV training matrices for GPV Headquarter and Affiliate PV staff and its implementation and tracking in the electronic Learning Management System ISOtrain.

Core Job Responsibilities:

• Independently liaises with relevant PV and non-PV stakeholders (e.g., Clinical Department, Medical Affairs, Regulatory Affairs within l&D Operational Excellence and non l&D functions, as applicable):
  • to ensure PV training is rolled out to all EPD employees.
  • to ensure that the PV training matrices for all PV personnel is up to date and compliant.
  • to ensure PV training requirements for all global and regional EPD non-PV employees is communicated accordingly.
• Assigns training modules and retrieve training records in ISOtrain.
• Ensures that local and global procedures related to GPV processes are established and kept current.
• Establishes and manages GPV procedures in the electronic Document Management System (eDMS) and departmental controlled forms.
• Reviews procedural changes in interface EPD procedures for impact and coordinates GPV responses and initiates Implementation Reviews for PV.
• Business Administrator role for eDMS.
• Site System Administrator back up role for Hanover Site.
• Supports GPV users of the eDMS in case of issues via the OMS support process with the vendor.
• Assists with authoring, editing, review, approval, training, import and export of new and existing documents.
• Maintains a process for periodic review of documents.
• Supports processes for maintenance of the Pharmacovigilance System Master File (PSMF), according to Good Pharmacovigilance Practice Module II.
• Supports internal and 3rd party audits and health authority inspections.
• Tracks and reports on a regular basis KPls concerning PV system to the PV Compliance function.
• Oversight on GPV documents and their archive location(s).
• Act as administrator and coordinator of the GPV Sharepoint.
• Participates in a variety of GPV project teams to assure PV system compliance with international regulations.
• Participates in l&D wide training projects to ensure alignment of training processes throughout all l&D departments.
• Is PV representative in EPD Training Community.