Overview
Si le interesa solicitar este empleo, por favor, asegúrese de cumplir los siguientes requisitos que se enumeran a continuación.
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 general organization.
Responsabilidades
Lead risk management evaluation and resolution for assigned assets and projects
Own the overall scientific and clinical safety content for assets/indications
Ensure high-quality delivery of Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team outputs
Set safety content aligned to GPT strategy and define safety goals for TA and product plans
Define safety target product profile (TPP), Go/No Go criteria, and toxicity management guidelines
Contribute to study designs and concept development within programs
Chairs or directs Safety Management Team to maintain a safety/risk-benefit focus from inception to closure
Represent Alexion GPS in internal strategic or governance meetings and as external expert at DSMB or regulatory meetings
Detect, validate,



and manage safety signals pre- and post-approval to resolution
Evaluate aggregate safety data for regulatory documents (PSURs, DSURs, Risk Management Plans) and for internal decisions
Identify and manage updates to labeling (IB, CCSI, product information, PI/SmPC) as needed
Oversee safety sections of regulatory documents and interactions with authorities; contribute to MAAs/NDAs
Deliver balanced, statistically robust safety analyses to inform interpretations and proposals
Provide scientific/safety knowledge to Product Teams for data interpretation
Exercise flexibility for related duties as needed
Requisitos principales
MD or equivalent degree with demonstrated patient safety and/or clinical/drug development xqbhyrx experience
Strong problem-solving and decision-making with ability to generate innovative options for complex problems
Ability to manage multiple overlapping complex tasks and timelines across projects
Knowledge of GPS deliverables, standards, and processes; understanding of US/EU safety regulations pre- and post-marketing
Office-based role with ability to use computer and engage in remote communications and problem solving
strong verbal and written communication
excellent independent judgment
time-management and project-management skills
safety data analysis and interpretation
regulatory documentation (PSURs, DSURs, risk management plans)
safety signal detection and management

📌 Medical Director, Global Patient Safety (Barcelona)
🏢 Alexion Pharmaceuticals
📍 Barcelona