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 c?ur 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.
Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail. SANOFI CHC PURPOSE AND ASPIRATION At Sanofi CHC, we have one shared purpose - we work passionately, every day, to ‘serve healthier, fuller lives. Our marketing philosophy is driven by this purpose and everything we do is centered around people –, our customers, healthcare professionals, and our employees – across the world. We are building brands that serve 1bn consumers worldwide, so that they can live healthier, fuller lives. In order to do this better than anybody else, we aspire to become the most consumer-centric Fast Moving Consumer Healthcare Business. We want to be market shapers and achieve category leadership in the categories that we play in - delivered through strong global-local partnership. We are a people first business, placing consumers at the heart of everything we do through uncovering and activating deep consumer and shopper insights, for example. As a top 3 global CHC player, we want to raise the bar in terms of our strategic and operational capabilities to enable sustainable, above-market growth. In order to achieve this, we need strong talents that will help us shape the future of CHC while sharing our core values of courage, teamwork, respect, and integrity. ABOUT THE JOB The purpose of this position is to ensure that routine Pharmacovigilance (PV) Compliance activities are conducted in accordance with applicable Regulations, and to identify potential risks of non-compliance. This includes compliance activities for ICSRs, PSRs and Submissions to Health Authorities. Main Responsabilities Run compliance investigations and Root Cause Analysis on ICSRs, PSRs and Submission to Health Authorities, jointly with affiliates, CHC PV stakeholders or external partners, ensuring true root cause is identifiedPrepare KPI reports and share with key stakeholdersIdentify potential critical and major systemic deviation and escalate as requiredIdentify Trends during ongoing investigations and as part of retrospective reviewsParticipate to the remediation of compliance gaps in collaboration with stakeholders owning the corrective and preventive actions (CAPA)Ensure that the QPPV is informed about Compliance metrics thoroughly and regularly Key working relationships of CHC Global Head Quality & Excellence Consumer Safety & Evidence their team CHC PV teamsCHC Clinical Operations TeamQPPV OfficeCHC Global QualityCHC Quality & Excellence Scientific AffairsSanofi Quality Teams ABOUT YOU Education Scientific background: Pharm D or Master Degree in Human Health Sciences Required knowledge and/or experience Minimum of 5 years of experience in ICH-GxP-related Quality operations and Compliance, of which 2 years experience in PVKnowledge of international regulations/Guidelines/Good Practices pertaining to the ICH-GxPGood depth understanding of Quality Risk Management and Quality systemsExperience in PV Audits and Inspection ManagementExcellent communication skills (oral and written)Excellent organizational and planning capabilitiesAbility to work in transversal/cross functional teamsExcellent teamwork and interpersonal skillsOrganized and detail oriented, efficient time managementAnalytic, pro-active and effective problem-solving skills Language skills Fluent spoken and written EnglishAn Additional language is desirable Cultural traits/P2W Behavior Push to go beyond the level we have operated until now: constantly challenge the status quo focusing on the priorities that will deliver the best outcomes and letting go what won’t: be intolerant to mediocracy, believe we can and must do better and aim at higher but never at the expenses of our values and judgmentPut the interest of the organization ahead of own of those of his/her team: consider both short and long term impact of decisions; puts collective and global goals above individual or local goals; share resources and capabilities with those with the greatest need and impact; enable decision making at appropriate levelAct in the interest of our patients and customers: actively engage with customers to know their current and future needs; brings an external perspective into decisionsTake action and do not wait to be told what to do: take smart and informed best bets with the information at hand and anticipate the consequences of her/his actions; use personal judgement and others’ advice to make bold and impactful decisions which move us forwardRole model our 4 values: teamwork, integrity, respect, courage Required Leadership Competencies Strategic Thinking - Ability to evaluate relevant areas of operation, formulate objectives and set priorities in a contextually relevant way, and develop plans consistent with long-term organizational interestsBusiness Acumen - Ability to effectively use economic, financial, market, stakeholder, and industry-specific indicators to fully understand and improve business resultsJudgement - The ability to draw logical conclusions based on acquired information and analytical rigor in problem-solving, the ability to make effective decisions even when information is ambiguous or incompleteTeam Leadership - Ability to build cohesive, high-performance teams that take accountability and achieve required resultsInterpersonal relationships - Treating others with courtesy, sensitivity, and respectChange Leadership - The ability to demonstrate support and drive for innovation and organizational transformationPersonal Leadership - Personal leadership translates into courage, choice, and commitment through the pursuit of excellence, trust, and accountability. Ability to put patient, stakeholder, and organizational interests above personal interestsDrive -Takes the lead and initiates activities with a high degree of passion and commitment as well as the drive, desire and need to achieve challenging goals, to improve performance or to meet personal standards of excellenceLearning Agility - Ability to navigate first time/unfamiliar situations effectively by extrapolating from other areas of expertise and knowledge. Ability to continuously improve and develop self #LI-DNI