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Experteer Overview In this role you will provide medical leadership for patient safety across clinical development and post-marketing for assigned products. You will oversee medical review, signal detection/management, and benefit–risk assessment in line with global regulations, partnering with Clinical, Regulatory and Medical Affairs to ensure proactive risk management and timely safety communications. You will work toward inspection readiness and engage with health authorities as needed, shaping safety strategies across development and post-market activities. Compensaciones / Beneficios • Lead medical review of individual and aggregate safety data; participate in safety review meetings • Oversee signal detection/evaluation and benefit–risk assessments; recommend risk minimization actions • Author/review DSURs, PBRER/PSURs, RMPs, and labeling updates; contribute to regulatory responses • Advise on protocol safety design, stopping rules, and DMC interactions; support FIH and pivotal studies • Ensure PV compliance and maintain audit/inspection readiness with vendors and affiliates Responsabilidades • MD • 8–10+ years in pharmacovigilance/drug safety including clinical safety, medical review and signal management • Knowledge of GVP, GCP and global safety regulations • Strong clinical judgment • Fluency in English and good communication skills Requisitos principales •

Experteer Overview In this role you ensure the Pharmacovigilance Quality System remains compliant and efficient, guiding audits, inspections, and documentation to support safe medicines. You work with a cross-functional team and external partners to uphold regulatory standards and continuous improvement. Your impact lies in readiness for inspections, robust audit programs, and alignment of GVP with evolving requirements. This is an opportunity to shape QA in drug safety within a patient-focused dermatology company. Compensaciones / Beneficios • Maintain the Quality System for Pharmacovigilance in line with Almirall policies, ICH, EU GVP modules, and relevant regulations • Design and manage a risk-based GVP audit plan; coordinate or oversee audits of affiliates, CROs/vendors, and internal audits • Report audit findings to management and ensure closure of significant issues • Lead preparation and management of inspections by Competent Authorities and third-party audits, developing an inspection readiness plan • Review and approve procedures and key documents to ensure compliance with Drug Safety regulations • Select and supervise outsourced QA activities related to pharmacovigilance (audits, mock inspections, training) • Involve in due diligence of development products as needed • Promote continuous improvement of the GVP Quality System based on audit findings and regulatory changes Responsabilidades • Life science degree (Pharmacy, Chemistry, Biology, etc.) Requisitos principales •

Te apasiona la docencia en el bárea de gestión y políticas públicas /b? ¿Te gustaría poder incluirte en nuestra base de datos para la captación docente de las futuras necesidades docentes que nos surjan? Si tu respuesta es afirmativa, ¡esta es tu oferta! /p pDesde la bUniversidad Europea de

Posibles materias a impartir: /b /pulliGestión inmobiliaria: fundamentos, valoraciones y operaciones inmobiliarias /liliDisciplina urbanística, potestad sancionadora y delitos urbanísticos /liliLa actividad administrativa limitativa o de policía en el ámbito urbanístico (licencias urbanística