PATIENT SAFETY SENIOR MANAGER

Manage corporate pharmacovigilance activities in collaboration with internal and external stakeholders, ensuring the safety of Almirall's marketed and investigational products. 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 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. Conduct review of PSURs and Risk Management Plans.