Farmacovigilancia

Responsibilities and functions: ¿ Pharmacovigilance activities related to the assigned therapeutic area: - Case management: Manage collection, processing, and submission to local HA of all ICSRs for all Sanofi products from all sources according to the defined timelines and quality parameters. Monitor the compliance for ICSRs and implement CAPAs as applicable. - Periodic Safety Reports (PBRER): Analyse Periodic Safety Reports and their possible impact at the local level. - Determine the regulatory action and, if appropriate, prepare the referral to health authorities. - Analysis and validation of the safety information of the Technical Data Sheets, Package Leaflets, Instructions for Use, labelling, and Packaging Material containing safety information versus the reference documentation for submission by Registries to the Competent Authority (AEMPS, EMA, AESAN, etc.). - Respond diligently to safety questions received in the PV department, from consumers, healthcare professionals, in coordination with the department's Country safety Manager. - Knowledge and application of PV legislation. - Collaborate with the Country Safety Manager and Country Safety Head in the management and sending of Safety Letters addressed to Healthcare Professionals. - Collaborate with the Country Safety Manager and Country Safety Head in the identification and management of Product Alerts. - Collaborate with the Country Safety Manager and Country Safety Head in the detection of signals. Requisitos del puesto: Skills, experience and knowledge requirements ¿ Graduate in health sciences ¿ Previous work experience in pharmacovigilance ¿ Knowledge of the principles of pharmacovigilance ¿ Languages: High level of Spanish and English ¿ Good communication and presentation skills ¿ High teamwork spirit ¿ Organized and detail oriented ¿ Efficient time management ¿ Capacity to work under pressure, to prioritize activities, to identify and escalate issues as appropriate Formación: Licenciado Idiomas: Inglés : C2 Conocimientos: farmacovigilancia Experiencia: 1 año Tus beneficios: Salario muy competitivo Contrato de sustitución maternidad Inicio previsto: 1/05 Bonus según objetivos, cheques restaurante y un plus para cubrir el internet de tu casa Alta Flexibilidad horaria 50% en casa 50% en oficina