Pharmacovigilance Technician

hace 2 semanas

Madrid, España Empresa Reconocida A tiempo completo

.1750 Viatris Pharmaceuticals S.L. At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless of geography or circumstance; Leadership - Advancing sustainable operations and innovative solutions to improve patient health; Partnership - Leveraging our collective expertise to connect people to products and services. The position holder is responsible for support on pharmacovigilance requirements performed on a local level for all medicinal products and parapharmaceutical products. This includes local pharmacovigilance activities, compliance with global and local procedures, archiving of all local pharmacovigilance documents, and implementing processes to improve quality. Every day, we rise to the challenge to make a difference, and here's how the Pharmacovigilance (PV) Technician role will make an impact: Key responsibilities for this role include: Monitor PV mailbox and other communication channels for incoming ICSRs on drugs and parapharmaceuticals (medical devices, cosmetics, and food supplements). Record and review incoming ICSRs. Translate ICSRs into English language and perform Quality checks. Enter relevant data into local ICSR tracking tool and perform follow-up activities. Liaise with relevant stakeholders (e.G., QA, Medical, Service Providers) to ensure all relevant data are available. ICSR reconciliations with applicable stakeholders. Format and archive ICSR-relevant documents according to PV processes and policies. Local literature search. Investigate any instances of non-compliance and manage PV investigation forms. Contribute to Audit and Inspection preparations and the respective CAPAs. Participate in the creation and update of applicable local PV procedures. Perform related trainings of other departments and/or third parties. Assist in Risk Management Plan activities. Assist in CEP (Customer Engagement Program) activities. Assist in activities related to non-interventional studies. Identify, negotiate and establish the applicable pharmacovigilance agreements. Maintain them updated. Assist in local PSUR/ACO work. Perform other duties as assigned. The minimum qualifications for this role are: Bachelor's degree or equivalent degree with related health science. Prior experience in PV and case processing of minimum 1-2 years. Fluent in Spanish and English language (can take an active role in business discussions and can perform relatively complex tasks), C1 Advanced qualification or equivalent. Knowledge of good documentation practice and quality management systems. Viatris is an equal opportunity employer

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