Safety International

il y a 4 semaines

SACLAY, France Servier Temps plein
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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