Descripción de la oferta
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.
ResponsabilidadesLead medical review of individual and aggregate safety data; participate in safety review meetingsOversee signal detection/evaluation and benefit–risk assessments; recommend risk minimization actionsAuthor/review DSURs, PBRER/PSURs, RMPs, and labeling updates; contribute to regulatory responsesAdvise on protocol safety design, stopping rules, and DMC interactions; support FIH and pivotal studiesEnsure PV compliance and maintain audit/inspection readiness with vendors and affiliates
Requisitos principalesMD8–10+ years in pharmacovigilance/drug safety including clinical safety, medical review and signal managementKnowledge of GVP, GCP and global safety regulationsStrong clinical judgmentFluency in English and good communication skillsstrong communication skillsclinical judgmentleadership abilitiespharmacovigilancemedical reviewsignal detection
