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PV Excellence Expert

PV Excellence Expert

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PV Excellence Expert

  • Location:


  • Sector:

    Pharmacovigilance - Pharma

  • Contact:

    Edward Jessel

  • Salary:

    £350 - £450 per day

  • Job type:


  • Contact email:

  • Job ref:


  • Published:

    about 1 year ago

  • Duration:

    6 months

  • Startdate:


Pharmacovigilance Excellence Expert - Periodic reporting process

MSI Pharma are working with a global Pharma company to hire a PV Excellence Specialist until the end of the year.

Task need:

  • To maximise the efficiency of processes, to meet new levels of demand and to remain compliant with health authority requirements, AZ should establish a cross-portfolio view of (EU) health authority Periodic Safety Report Assessment comments.
  • This would make it possible to leverage this regulatory intelligence to:
    • provide a measure of PSR content quality
    • improve our PSR template(s) to drive right first time submissions of Periodic Safety Reports (thus reducing the number of follow-up requests)
    • inform regulatory strategy in responding to health authority follow-up requests

Task description:

  • Project manager / IT savvy & support with further testing, project build, delivery & implementation, with input & advice from internal resources to:
  • Potentially run pre-tool pilot
  • Support appropriate tool development
  • Implement and run pilot (with inputs from process owners) + monitor outputs underway
  • Ensure that the process, communications to support completion and implementation to BAU of the tool is optimised and documented

Skillsets required:

  • Project management experience (working knowledge of project management methodologies)
  • Develops and manages execution of the project
  • Solid pharmacovigilance experience, especially within Periodic Safety Reports and (EU) health authority Assessment Reports
  • IT savvy, including Excel superuser and advanced knowledge of Sharepoint applications