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
