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 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 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)
🏢 Jobrapido
📍 Barcelona