Patient safety senior manager

Estamos construyendo el futuro de la dermatología médica centrándonos en las necesidades no cubiertas de los pacientes y dando a las personas el espacio para pensar de forma independiente, asumir responsabilidades y generar un impacto que de verdad importe. Nuestro propósito es sencillo: transformar la vida de los pacientes abordando necesidades reales. Trabajamos con rigor, actuamos con valentía, simplificamos lo complejo y enfocamos la innovación allí donde realmente marca la diferencia. Reconocidos como Top Employer en España desde 2008 y en Alemania desde 2025, seguimos invirtiendo en un entorno donde las personas pueden crecer y avanzar. Si quieres hacer las cosas de otra manera, este es tu lugar. Help shape the future of patient safety. At Almirall, we are committed to improving the lives of patients through science, innovation, and care. We are looking for a medical safety professional who is passionate about protecting patients and ensuring the highest standards of pharmacovigilance across our investigational and marketed products. In this role, you will work at the intersection of clinical development, post-marketing surveillance, and regulatory compliance, collaborating with global cross-functional teams to ensure that patient safety remains at the heart of everything we do. POSITION SUMMARY / MISSION Responsible for the management of corporate pharmacovigilance activities in collaboration with internal and external stakeholders, ensuring the safety of Almirall’s marketed and investigational products. This role provides operational and medical support across clinical development and post-marketing safety surveillance, contributing to regulatory compliance and patient protection. CORE RESPONSIBILITIES - Provide operational and medical support to clinical trial activities, including SAE management, medical review, reconciliation, unblinding, and safety monitoring - Lead the preparation and medical input for aggregate safety reports (e.g., DSURs) and other periodic regulatory submissions - Review safety-related sections of clinical documentation, including protocol synopses, Data Management Plans, and Safety Topics of Interest - Act as medical lead for the development of Safety Reporting Plans Participate actively in clinical study team meetings, both internally and with CROs Support non-interventional studies, market research, and registries, including ICSR management and safety monitoring - Conduct post-marketing safety surveillance, including medical review and assessment of safety data Support the Patient Safety Director and EU QPPV in fulfilling internal and regulatory responsibilities Contribute to the Pharmacovigilance Quality Management System and ensure implementation of relevant procedures - Perform tasks related to safety databases and signal detection (as medical writer or reviewer) Conduct review of PSURs and Risk Management Plans - REQUIRED EDUCATION AND EXPERIENCE - Medical science degree and Postgraduate training in pharmacovigilance, clinical safety, or epidemiology are preferred. - Experience in pharmacovigilance or clinical safety within a corporate setting is highly valued PREFERRED SKILLS AND COMPETENCIES - Proficiency in safety databases - Strong understanding of Good Pharmacovigilance Practices (GVPs) and applicable regulatory frameworks