{"id":944,"date":"2018-04-13T12:33:14","date_gmt":"2018-04-13T10:33:14","guid":{"rendered":"http:\/\/www.universalmedica.com\/interview-metier-responsable-pharmacovigilance\/"},"modified":"2021-05-19T17:02:50","modified_gmt":"2021-05-19T15:02:50","slug":"interview-metier-responsable-pharmacovigilance","status":"publish","type":"post","link":"https:\/\/www.universalmedica.com\/fr\/interview-metier-responsable-pharmacovigilance\/","title":{"rendered":"Interview m\u00e9tier \u2013 Emmanuelle B. : Responsable Pharmacovigilance"},"content":{"rendered":"<style>p{ text-align:justify;} <\/style>\n<h2><em><img decoding=\"async\" class=\"alignleft size-full wp-image-5692\" style=\"margin-right: 15px;\" src=\"http:\/\/www.universalmedica.com\/wp-content\/uploads\/2021\/04\/Emmanuelle-B.jpg\" alt=\"Emmanuelle B\" width=\"150\" height=\"200\" \/>Pr\u00e9sentation<\/em><\/h2>\n<p>Je suis pharmacien (PharmD) et j\u2019ai une th\u00e8se d\u2019Universit\u00e9 en Pharmaco\u00e9pid\u00e9miologie (PhD). J\u2019ai ensuite travaill\u00e9 pendant 15 ans en tant que praticien attach\u00e9 au Centre R\u00e9gional de Pharmacovigilance (CRPV) de Toulouse avant de rejoindre Universal Medica en tant que responsable Pharmacovigilance (PV). Durant ces 15 ann\u00e9es, j\u2019ai r\u00e9alis\u00e9 de nombreuses expertises pour l\u2019<a href=\"http:\/\/ansm.sante.fr\/ target=\" rel=\"nofollow\">ANSM<\/a>, notamment en oncologie.<\/p>\n<p>&nbsp;<\/p>\n<h2><em>Quel est ton r\u00f4le en tant que responsable PV ? <\/em><\/h2>\n<p>En tant que responsable PV, je suis en charge d\u2019une \u00e9quipe de charg\u00e9s de pharmacovigilance et d\u2019information m\u00e9dicale. Nous accompagnons les laboratoires qui ont des besoins en pharmacovigilance, nutrivigilance, cosm\u00e9tovigilance ou mat\u00e9riovigilance. Nous intervenons dans\u00a0:<\/p>\n<p>1. Identification des cas d\u2019effets ind\u00e9sirables ou situation sp\u00e9ciale de pharmacovigilance gr\u00e2ce \u00e0 l\u2019information m\u00e9dicale, dans la litt\u00e9rature (base de donn\u00e9es \u00e9lectroniques, veille dans les revues non index\u00e9es) ou dans la base de donn\u00e9es Eudravigilance de l\u2019European Medicines Agency (<a href=\"http:\/\/www.ema.europa.eu\/ema\/\" target=\"_blank\" rel=\"nofollow noopener\">EMA<\/a>) (requ\u00eate L2A &amp; <em>medical literature monitoring<\/em>).<\/p>\n<p>2. Traitement des cas\u00a0: les cas sont saisis ou import\u00e9s dans les bases de donn\u00e9es de chaque client. Certains cas doivent \u00eatre soumis \u00e0 l\u2019EMA.<\/p>\n<p>3. D\u00e9tection de signal\u00a0: les cas recueillis nous permettent d\u2019identifier la survenue d\u2019un signal de pharmacovigilance. En pr\u00e9sence d\u2019un signal, celui-ci doit \u00eatre \u00e9valu\u00e9 et analys\u00e9 afin de d\u00e9terminer s\u2019il s\u2019agit d\u2019un risque. Si le risque est valid\u00e9, les autorit\u00e9s doivent \u00eatre inform\u00e9es.<\/p>\n<p>4. R\u00e9daction de rapports de s\u00e9curit\u00e9\u00a0: ces rapports, qui int\u00e8grent toutes les donn\u00e9es administratives, commerciales, sur le b\u00e9n\u00e9fice et le risque, doivent \u00eatre transmis \u00e0 l\u2019EMA.<\/p>\n<h2><em>Quel est l\u2019impact de la nouvelle r\u00e9glementation en pharmacovigilance sur votre travail ?<\/em><\/h2>\n<p>Aujourd\u2019hui, avec les <a href=\"\/?p=5370\">nouvelles fonctionnalit\u00e9s d\u2019EudraVigilance<\/a>, les laboratoires doivent importer dans leur propre base de donn\u00e9es, tous les cas transmis dans la base Eudravigilance par les autorit\u00e9s comme l\u2019ANSM ou par d\u2019autres laboratoires pharmaceutiques, si un de leur m\u00e9dicament est consid\u00e9r\u00e9 comme suspect. Ceci impacte la volum\u00e9trie des cas \u00e0 traiter pour les laboratoires pharmaceutiques.<\/p>\n<p>Par ailleurs, les cas non graves doivent d\u00e9sormais \u00eatre soumis \u00e0 EudraVigilance, dans les 90 jours. Une nouvelle fonctionnalit\u00e9 d\u2019Eudravigilance est \u00e9galement en cours de d\u00e9ploiement, il s\u2019agit d\u2019EVDAS, un outil de d\u00e9tection du signal.<\/p>\n<p>Nous avons d\u00fb nous former et anticiper ces changements, pour pouvoir apporter notre expertise et un support op\u00e9rationnel \u00e0 nos clients, adapter nos process et r\u00e9viser la documentation qualit\u00e9 en cons\u00e9quence.<\/p>\n<h2><em>Quelle est la valeur ajout\u00e9e de ton poste pour le client\u00a0?<\/em><\/h2>\n<p>Nos clients b\u00e9n\u00e9ficient de l\u2019expertise et de la r\u00e9activit\u00e9 de toute l\u2019\u00e9quipe, et d\u2019un interlocuteur privil\u00e9gi\u00e9 pour simplifier la communication. Ayant personnellement travaill\u00e9 en CRPV et pour l\u2019ANSM, je connais bien le fonctionnement des autorit\u00e9s\u00a0et leurs attentes. Je suis \u00e9galement responsable de m\u2019assurer du respect des d\u00e9lais de traitement des cas d\u00e9tect\u00e9s ou de soumission des rapports. Enfin, ce poste me permet de piloter diff\u00e9rents projets pour diff\u00e9rents clients et d\u2019am\u00e9liorer les pratiques\u00a0en pharmacovigilance pour tous.<\/p>\n<p><em>Interview d&rsquo;Emmanuelle B. &#8211; Responsable Pharmacovigilance<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Pr\u00e9sentation Je suis pharmacien (PharmD) et j\u2019ai une th\u00e8se d\u2019Universit\u00e9 en Pharmaco\u00e9pid\u00e9miologie (PhD). J\u2019ai ensuite travaill\u00e9 pendant 15 ans en tant que praticien attach\u00e9 au Centre R\u00e9gional de Pharmacovigilance (CRPV) de Toulouse avant de rejoindre Universal Medica en tant que responsable Pharmacovigilance (PV). Durant ces 15 ann\u00e9es, j\u2019ai r\u00e9alis\u00e9 de nombreuses expertises pour l\u2019ANSM, notamment [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":682,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[130,134],"tags":[],"class_list":["post-944","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-entreprise","category-pharmacovigilance"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Interview m\u00e9tier \u2013 Emmanuelle B. : Responsable Pharmacovigilance - Universal Medica<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.universalmedica.com\/fr\/interview-metier-responsable-pharmacovigilance\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Interview m\u00e9tier \u2013 Emmanuelle B. : Responsable Pharmacovigilance - Universal Medica\" \/>\n<meta property=\"og:description\" content=\"Pr\u00e9sentation Je suis pharmacien (PharmD) et j\u2019ai une th\u00e8se d\u2019Universit\u00e9 en Pharmaco\u00e9pid\u00e9miologie (PhD). J\u2019ai ensuite travaill\u00e9 pendant 15 ans en tant que praticien attach\u00e9 au Centre R\u00e9gional de Pharmacovigilance (CRPV) de Toulouse avant de rejoindre Universal Medica en tant que responsable Pharmacovigilance (PV). 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