RAPV Specialist
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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. Your mission Regulatory Affairs: Maintain lifecycle for existing products, including license renew, PMF renew, post-marketing variations, etc. Support product license registration and PMF registration. Contribute to the discussion of registration plan with both local and global stakeholders. Monitor Regulatory regulations and communicate relevant updates to related stakeholders. Pharmacovigilance Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for medical care products. Perform local literature search and report the identified adverse event. Manage submission/distribution of safety reports/updates to Local Health Authorities. Health Safety Environment (HSE) Support in maintaining comprehensive HSE management systems, including identifying hazards and implement controls to mitigate risks. Coordinate the HSE training programs to employees. Assess the HSE compliance with the group's requirement that constitute the safety basics for our activities. Dermo-cosmetic Support for Export Market Fulfil Dermo-cosmetic distributors' needs for PIF and scientific dossier inquiries. Regularly monitor the latest regulatory change for cosmetic industry. To monitor of cosmetic advertisement compliance for both own brands and competitors. Parallel export/import tracking. Who you are ? We 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.
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