Qualité Sécurité Environnement

Informations sur l'entreprise

Nom de l'entreprise : SANOFI
Ville : Bridgewater, NJ 08807

Détails du contrat

Type de contrat :
Type de métier : Pharmacovigilance
Date de publication: 18/11/2021

A propos du recruteur

La vocation de Sanofi est d’accompagner celles et ceux confrontés à des difficultés de santé. Entreprise biopharmaceutique mondiale spécialisée dans la santé humaine, nous prévenons les maladies avec nos vaccins et proposons des traitements innovants. Nous accompagnons tant ceux qui sont atteints de maladies rares, que les millions de personnes souffrant d’une maladie chronique. Sanofi et ses plus de 100 000 collaborateurs dans 100 pays transforment l’innovation scientifique en solutions de santé partout dans le monde. Sanofi, Empowering Life, donner toute sa force à la vie. Chez Sanofi, la diversité et l’inclusion sont au cœur de notre fonctionnement et sont intégrées à nos Valeurs fondamentales. Nous sommes conscients que pour exploiter véritablement la richesse que la diversité nous apporte, nous devons faire preuve d’inclusion et créer un environnement de travail où ces différences peuvent s’épanouir et être développées pour améliorer le quotidien de nos collègues, patients et clients. Nous respectons et valorisons la diversité de nos collaborateurs, leurs parcours et leurs expériences dans un objectif d’égalité des chances pour tous.

Description du poste

The Pharmacovigilance Scientist (PVS) is a Safety Expert who is responsible for performing core pharmacovigilance activities on a product, or group of products in a therapeutic area or franchise, in partnership with the Global Safety Officer (GSO) to identify signals and evaluate safety data for both marketed products and products in clinical development. This includes performing proactive signal detection and safety management committee activities, authoring safety evaluations, defining scope and methodology, in agreement with the GSO, for aggregate safety reports, conducting preliminary safety analysis, preparing ad hoc Heal Authority responses, driving the end-to-end signal management process for assigned products (i.e., signal tracking, data analysis, leading review meetings, presenting, etc.) in collaboration with the GSO and Pharmacoepidemiology. The PVS also partners with the Safety Team to manage other safety related activities associated with new drug applications / regulatory filings, benefit risk assessment and safety risk management and support activities related to risk minimization including dRMP/RMPs. The PVS manages the coordination and oversight to outsourced activities (i.e., signal detection reports, safety evaluation reports). The nature and scope of PVS vendor oversight include the following activities specific to Global Business Unit (GBU): Determines tasks to be outsourced on a unit; Oversees tasks outsourced to service providers for respective GBU; Provides clear direction to vendor for expected deliverables and timelines for completion; Provides background information and necessary interval and cumulative data for safety analysis(es) including (but not limited to) most current company core labeling and PBRER, signal source, and safety database and literature outputs; Resolves vendor questions and escalates issues to in-house PV Science Manager as appropriate Provides regular vendor feedback to in-house PV Science Manager for inclusion into the Vendor Operational Governance Meetings; Reviews and approves vendor invoices related to outsourced PVS tasks to ensure accuracy of unit charges for respective GBU. Education: Minimum Bachelors of Science or Health Care Professional (RN, BSN, Nurse Practitioner or Physician Assistant, RPh); or preferred advanced health care discipline degree (PharmD, PhD, Masters of Science, etc.) or equivalent qualification. Experience: Preferred 2 years with relevant experience (including industry experience) with a working knowledge of drug safety and risk management, and understanding of drug development, basic knowledge of regulatory guidelines and medical coding (i.e. MedDRA). Working knowledge of common data processing software (i.e., Excel, PowerPoint, Word) and database systems At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA#LI-SA

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