Safety International & Eea Qppv Office Assistant H/F
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 Directors 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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