Overview
Experiencia, cualificaciones y habilidades interpersonales, ¿tiene todo lo necesario para triunfar en esta posibilidad? Descúbralo a continuación.
In this role you will lead safety science for complex oncology products, shaping proactive pharmacovigilance and risk management across development stages. You work closely with cross-functional teams to deliver safety strategies, regulatory documents, and submissions that support global programs. You will mentor PV scientists, drive governance and safety discussions, and present intricate issues to governance bodies. This is a strategic, senior IC position that fuels the oncology mission by ensuring safe, effective medicines reach patients. Located in Barcelona with a blend of on-site and remote work, the role offers high-impact work on cutting-edge cancer therapies.
Responsabilidades
Provide subject matter expertise in oncology PV for multiple products
Lead proactive PV strategy and risk management planning for complex products
Coordinate safety aspects of Global Risk Management Plans and REMS with partners
Drive cross-functional process improvement within Patient Safety




Serve as Safety Strategy and Management Team Leader for complex/multiple products
Present complex safety issues to Safety Information Review Committee
Lead safety strategy for periodic regulatory documents (PBRERs, PSURs, DSURs)
Lead safety strategy for regulatory submissions (NDA/BLA, MAA) with GSP and others
Negotiate and contribute to PS components of third-party contracts
Take accountability for safety issue resolution and cross-functional alignment
Participate in due diligence activities
Provide training and mentorship to GSPs and PV Scientists
Requisitos xqbhyrx principales
A degree in life sciences (or similar field) with advanced PV/Clinical Development experience
Excellent written and verbal English
Advanced knowledge of PV regulations
Clinical Development (Early and/or Late Phase)
Post-Marketing surveillance
MAA/BLA Submissions
Periodic Reports
Risk Management Plans (from scratch)
Governance Board Interactions
leadership
cross-functional collaboration
strategic thinking
PV regulations
Global Safety reporting
Risk Management Plans

📌 Director, Principal Patient Safety Scientist Oncology (Barcelona)
🏢 AstraZeneca
📍 Barcelona