Descripción de la oferta
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. Our purpose is simple: to transform patients’ lives by addressing real needs. We work with care, act with courage, keep things simple and focus our innovation where it makes a difference. Recognised as a Top Employer in Spain since 2008 and in Germany since 2025, we continue to invest in an environment where people can grow and move forward. If you care differently, you belong here. MISSION The Associate Director, Safety Physician provides medical leadership for patient safety across clinical development and post-marketing for assigned products. The role oversees medical review, signal detection/management, aggregate reporting, and benefit–risk assessment in compliance with global regulations and GVP. The incumbent partners with Clinical, Regulatory, Epidemiology, and Medical Affairs to ensure proactive risk management, timely safety communications, and inspection readiness; Dé el siguiente paso en su carrera profesional ahora: desplácese hacia abajo para leer la descripción completa del puesto y envíe su solicitud. and engages with healthauthorities as needed. Core Responsibilities Lead medical review of individual and aggregate safety data; chair or contribute to 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 pivotalstudies. Ensure PV compliance and audit/inspection readiness with vendors and affiliates. Required Education And Experience MD (Doctor of Medicine) degree required. 8–10+ years of experience in pharmacovigilance. Knowledge of ICH,GVP, and global safety regulations. Fluency in English. Preferred Skills And Competencies Experience across both clinical development and post-market safety. Authority interactions and inspection experience. xkdbapo Strong clinical judgment, communication, and cross-functional leadership. #J-18808-Ljbffr
