Introduction to role
Are you ready to build clinical safety plans that safeguard patients while accelerating breakthrough medicines across a diverse pipeline? How would you use your medical judgment to anticipate and mitigate risk before it reaches the clinic or the market?
As Medical Director, Patient Safety Physician, you will coordinate the clinical safety agenda for assigned programs across all stages of development and post-approval. You will partner with scientific, clinical, regulatory and informatics experts to turn sophisticated safety evidence into clear, decisive actions that influence program direction, labelling and submissions. This role gives you the freedom to ask the right questions, make ambitious decisions, and focus efforts where they have the biggest impact on patients and the business.
Accountabilities
Lead the approach to clinical safety for assigned products during development and after launch. Align with governance. Identify risks and propose mitigation and minimisation measures. Set safety go/no-go criteria and give to TPP/TPC.



Develop safety submission strategies, respond to regulatory safety questions, and lead the risk part of benefit–risk assessments.
Review and endorse core patient risk management plans and logs; provide medical expertise to safety specifications, pharmacovigilance plans and risk-minimisation activities; ensure appropriate implementation within product reference safety information globally.
Represent Patient Safety on clinical and project teams; establish and chair Safety Management Teams as needed; give to ad-hoc teams addressing urgent safety issues; present safety information at investigator and commercial meetings.
Provide strategic clinical safety input into development planning; define project-specific safety requirements; review and approve investigator brochures, protocols, informed consents and final study reports; support external data monitoring committees where appropriate.
Supervise surveillance activities

📌 Medical Director, Patient Safety Physician (España)
🏢 Astrazeneca
📍 España