Regulatory Vigilance Expert
il y a 2 jours
We are seeking a highly skilled Regulatory Vigilance Expert to join our team at Pierre Fabre Group.
Key Responsibilities- Monitor the vigilance regulatory environment and ensure the impact analysis of regulatory requirements on the vigilance system.
- Coordinate the network of local safety officers to ensure the implementation of local vigilance systems, in compliance with corporate procedures and vigilance regulatory requirements.
- Participate in the functioning of the EU QPPV office, ensuring the EU QPPV global oversight of the Pharmacovigilance System, as required by EU regulations.
- Contribute to vigilance Due Diligence activities and provide support on vigilance governance activities.
- Support the Corporate Vigilance Direction (CVD) in developing strategies, guidance, and processes for implementing new vigilance regulatory requirements.
- Analyze the impact of vigilance 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 internal communication and awareness on new regulatory texts.
- Analyze draft regulatory texts published by authorities or transmitted by associations, coordinate the review with involved vigilance units to provide consolidated comments.
- Participate in vigilance working groups of international industry associations.
- Participate in the implementation and maintenance of a local vigilance system in all countries where Pierre Fabre products are authorized/distributed.
- Coordinate and animate the LSO and Local QPPV network.
- Conduct individual regular meetings in a set of countries to maintain oversight of local vigilance activities, provide advice on vigilance processes, and/or facilitate interactions between corporate and local organizations.
- Provide support on 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 Local Safety Officers.
- May provide vigilance Regulatory Intelligence and bibliographic support for Due Diligence (DD) projects in the context of external acquisitions.
- May support the coordination of various governance committees.
- Support the creation and maintenance of quality documents.
- 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 vigilance regulations and various vigilance activities.
- Fluency in English. Spanish is an advantage.
- Good IT skills: pack office, collaborative tools.
Pierre Fabre Group is a leading international pharmaceutical company dedicated to improving people's lives through innovative healthcare solutions. We are committed to excellence and innovation in our products and services, and we are seeking talented individuals to join our team.
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