Who we are ?Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world, the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies.Its portfolio includes several medical franchises and international brands including Pierre Fabre Oncologie, Pierre Fabre Dermatologie, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive, Pierre Fabre Oral Care.Established in the Occitanie region since its creation, and manufacturing over 95% of its products in France, the Group employs some 10,000 people worldwide. Its products are distributed in about 130 countries. 86% of the Pierre Fabre Group is held by the Pierre Fabre Foundation, a government-recognized public-interest foundation, while a smaller share is owned by its employees via an employee stock ownership plan.In 2019, Ecocert Environment assessed the Group’s corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard and awarded it the “Excellence” level.Pierre Fabre is recognized as one of the "World's Best Employers 2021" by Forbes. Our group is ranked in the Top 3 in the cosmetics industry and in the Top 10 in the pharmaceutical industry worldwide.Your missionNous recrutons un(e) Vigilance Regulatory Advisor 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 activitiesDETAILED RESPONSIBILITIES1) 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 associations2) 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 Officers3)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 documentsIn 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 environmentAdditional 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 toolsWe are convinced that diversity is a source of fulfillment, social balance and complementarity for our employees, which is why our offers are open to all, without restriction.
