Category

Description

Essential Functions

Serve as the PSMF Administrator for the Jazz and PBL PSMFs ;
Coordinate the ongoing regular maintenance of the PSMFs and PSMF Summaries in accordance with the assigned schedule, and under the supervision of the Deputy QPPV.
Maintain schedule of updates and data requirements for the PSMFs
Ensure the content of the PSMFs is compliant vs GVP Module II requirements by liaising with key contributors from all relevant global functions
Ensure the content of the PSMFs is provided in a timel y manner , collating the data, resolving queries and ensuring review, approval and release of the document as appropriate
Upload completed PSMFs and PSMF Summaries into document repository and ensure relevant documentation is archived in accordance with company requirements
Ensure that the QPPV/Deputy are made aware of significant changes and updates of the PSMF content and/or format on a regular basis
Support the preparation and maintenance of PSMF-related documentation in other regions outside of the EU/EEA (e.g. National Pharmacovigilance Sub-System Files (PSSFs) for Arab League countries)
Ensure appropriate and current procedural documents are in place for the maintenance of the PSMFs
Perform other PSMF-related activitie s , as appropriate

Affiliates, Distributors , Marketing Partners , Third Party Service Providers) , Including But Not Limited t o

Provide support to the QPPV/Deputy for the oversight of activities and interactions with internal departments and external business partners (e.g.
participate to meetings , when required
set up meetings, prepare agendas and minutes, when required

Provide Support To The QPPV/Deputy For Internal PV Audits And Regulatory GPvP Inspection s , i Nc l Udin g
assisti ng with the readiness, preparation, facilitation and follow-up of PV audits and regulatory GPvP inspections
assisting with the development, management

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