Overview In this role you will lead safety and risk management activities for assigned clinical development programs or marketed products, ensuring safe and effective use for patients and healthcare providers. You will drive safety strategy, contribute to study design, and oversee safety content across regulatory and labeling deliverables. You will act as a medical safety expert within cross-functional teams and represent GPS in governance and regulatory contexts.

This position offers high-impact work at the interface of science, safety, and regulatory affairs within a integral organization.

ResponsabilidadesLead risk management evaluation and resolution for assigned assets and projectsOwn the overall scientific and clinical safety content for assets/indicationsEnsure high-quality delivery of Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team outputsSet safety content aligned to GPT strategy and define safety goals for TA and product plansDefine safety target product profile (TPP), Go/No Go criteria, and toxicity management guidelinesContribute to study designs and concept development within programsChairs or directs Safety Management Team to maintain a safety/risk-benefit focus from inception to closureRepresent Alexion GPS in internal strategic or governance meetings and as external expert at DSMB or regulatory meetingsDetect, validate,



and manage safety signals pre- and post-approval to resolutionEvaluate aggregate safety data for regulatory documents (PSURs, DSURs, Risk Management Plans) and for internal decisionsIdentify and manage updates to labeling (IB, CCSI, product information, PI/SmPC) as neededOversee safety sections of regulatory documents and interactions with authorities; contribute to MAAs/NDAsDeliver balanced, statistically robust safety analyses to inform interpretations and proposalsProvide scientific/safety knowledge to Product Teams for data interpretationExercise flexibility for related duties as needed

Requisitos principalesMD or equivalent degree with demonstrated patient safety and/or clinical/drug development experienceStrong problem-solving and decision-making with ability to generate innovative options for complex problemsAbility to manage multiple overlapping complex tasks and timelines across projectsKnowledge of GPS deliverables, standards, and processes; understanding of US/EU safety regulations pre- and post-marketingOffice-based role with ability to use computer and engage in remote communications and problem solvingstrong verbal and written communicationexcellent independent judgmenttime-management and project-management skillssafety data analysis and interpretationregulatory documentation (PSURs, DSURs, risk management plans)safety signal detection and management

📌 Medical Director, Global Patient Safety - barcelona
🏢 Jobrapido
📍 Barcelona