Safety International

The Safety International & EEA QPPV Office Assistant provides assistance in the organizational, administrative and technical coordination of the activities of the International unit & EEA QPPV Office.

Technical responsibilities and EEA QPPV Office
• Maintain tracking tables related to document the EEA QPPV oversight
• Supervise the Generic email box retaled to the QPPV and PV Agreements
• Contribute in the maintenance of the Global PSMF
• Coordinate the service agreements related to the international unit
• Ensure the organization of meetings : preparation of the meeting minutes and dissemination
• Contribute to the global tracking of service providers
• Contribute to the global tracking of digital media
• Contribute in the process of reconciliation with Global Legal department on Business agreements and PVA/SDEA
• Assist International Project Leads on their activities
• Prepare periodic LPV meetings: presentations, agenda, minutes and distribution
• Ensure maintenance of LPV tracking table
• Manage different tracking tables related to the management of the PVA/SDEA, the regulatory intelligence and LPV coordination.
• Distribute PVA/SDEA after finalization

Administrative responsibilities
• International Unit Director‘s agenda and the email account management
• Travel planning and expense reports for the International unit team
• Organizational support for audits and inspections
• Back-up assistance
• Management of the arrival of new employees (external/internal) within the unit
• Budget monitoring
• Assist the International unit Director in validating the leave of his N-1

General responsibilities
• Create and maintain quality documents related to her/his scope of activities and ensure that those quality documents are in line with the regulatory requirements
• Periodically reports on her/his activities to the direct line manager
• Identify potential risks in terms of activities under her/his scope and inform immediately her/his direct line manager
• Contribute to preparing inspections and audits by business partners for activities under the scope of periodic reports unit

Profile

Bilingual Assistant degree (Bac+2 or equivalent)
At least 5 years of experience within the pharmaceutical industry in the PV field at Corporate, in an international environment, as well as in EEA QPPV Office
Fluency in English.
Good IT experience: pack office and internal tool

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