15 ago
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Almirall
|
Cataluña
We’re building the future of medical dermatology by focusing on unmet patient needs and giving people the space to think independently, take ownership and make an impact that matters.We work with care, act with courage, keep things simple and focus our innovation where it makes a difference.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 integral cross-functional teams to ensure that patient safety remains at the heart of everything we do.POSITION SUMMARY / MISSIONResponsible 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 RESPONSIBILITIESProvide operational and medical support to clinical trial activities, including SAE management, medical review, reconciliation, unblinding, and safety monitoringLead the preparation and medical input for aggregate safety reports (e.g., DSURs) and other periodic regulatory submissionsReview safety-related sections of clinical documentation, including protocol synopses, Data Management Plans, and Safety Topics of InterestAct 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 monitor
📌 Patient Safety Senior Manager (Cataluña)
🏢 Almirall
📍 Cataluña