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Vigilance Regulatory Advisor- F/H- CDI - Boulogne-Billancourt, France - Pierre Fabre Group
Description
Your mission
Nous recrutons un(e) pour rejoindre la Direction Pôle International et EU QPPV.
Vous êtes en charge de la surveillance de l'environnement réglementaire en matière de vigilance et assurez l'analyse de l'impact des exigences réglementaires sur le système de vigilance.
Vous coordonnez le réseau des responsables locaux de la sécurité afin d'assurer la mise en œuvre des systèmes de vigilance locaux, conformément aux procédures de l'entreprise et aux exigences réglementaires en matière de vigilance.
Vous participez au fonctionnement du bureau QPPV de l'UE en assurant la surveillance globale du système de pharmacovigilance par le QPPV de l'UE, comme l'exigent les réglementations de l'UE.
Vous pouvez aussi contribuer aux Due Diligences en matière de vigilance et apporter un soutien aux activités de gouvernance.
Under the supervision of the Head of International Vigilances Unit & EU QPPV Deputy:
Monitor the vigilances regulatory environment and ensure impact analysis of regulatory requirements on the vigilance system
Coordinate the network of local safety officers in order to ensure the implementation of local vigilance systems, in compliance with the corporate procedures and vigilances regulatory requirements
Participate in the functioning of the EU QPPV office ensuring the EU QPPV global oversight of the Pharmacovigilance System, as required by the EU regulations
May contribute to vigilance Due Diligence activities and provide support on vigilances governance activities
DETAILED RESPONSIBILITIES
1) International Vigilances Regulatory Intelligence
Support the Corporate Vigilance Direction (CVD) in developing strategies, guidance and processes for implementing new vigilance regulatory requirements (including vigilance regulations applicable to medicinal products, medical device, food supplement, cosmetic, biocide/substances)
Analyze the impact of vigilances regulation changes
Ensure the maintenance of up-to-date country sheets for vigilance regulatory requirements with the support of country vigilance network
Ensure the tracking of all vigilance regulatory impacts
Ensure the internal communication and awareness on new regulatory texts
Analyze the draft regulatory texts published by the authorities or transmitted by associations, coordinates the review with the involved vigilances unit to provide consolidated comments
Participate in vigilance working groups of international industry associations
2) International Vigilances network coordination
Participate in the implementation and maintenance of a local vigilance system in all countries where Pierre Fabre (PF) products are authorized/distributed
Coordinate and animate the LSO and Local QPPV network
For a set of countries, conduct individual regular meetings in order to maintain oversight of local vigilance activities, provide advice on vigilance processes and/or facilitate interactions between corporate and local organizations
Provides a support on the business partnership management related to vigilance activities
Participate in the documentation of the PV system global oversight by the EU QPPV and coordinate the preparation of the PV System Master File (PSMF)
Provide support to the Local Safety Officers
3)Contribution to Vigilances Due Diligences / Governance activities
May provide vigilances Regulatory Intelligence and bibliographic support for Due Diligence (DD) projects in the context of external acquisitions
May support the coordination of the various governance committees
Support the creation and maintenance of quality documents
In respect of all activities in scope of your responsibility, you contribute to audits and inspections activities, including CAPA management, and monitor deviations.
Who you are ?
Scientific degree (pharmacist, biologist, bac+5)
At least 5 years of experience within the pharmaceutical industry in the field of pharmacovigilances, preferably in an international environment
Additional experience at affiliate level is a plus.
Good knowledge of the vigilance regulations and the various vigilance activities.
Fluency in English. Spanish is an advantage.
Good IT skills: pack office, collaborative tools
