03 ago
|
AstraZeneca
|
Barcelona
03 ago
AstraZeneca
Barcelona
Experteer Overview
Todos los candidatos deben asegurarse de leer atentamente la siguiente descripción del puesto y la información antes de enviar su solicitud.
In this role you will advance pharmacovigilance within AstraZeneca’s oncology programs, shaping safety strategy and oversight across drug development and regulatory submissions. You will collaborate with Global Safety Physicians, PV scientists, and cross-functional partners to interpret safety data and influence decisions that protect patients. The position offers high-impact work on a broad oncology portfolio and opportunities to contribute to regulatory safety content and risk management. This is a chance to join a mission-driven team delivering life-changing medicines.
Compensaciones / Incentivos
• Support safety strategy and requirements for assigned drug projects
• Aggregate, review, analyze and interpret safety data to inform safety decision-making
• Author and provide strategic safety input for regulatory documents (CTD sections, safety sections of regulatory reports, MAAs)
• Collaborate with GSP, PV Scientists, physicians, Clinical Project Teams, Global Regulatory Affairs and Global Commercial teams
• Deliver safety documentation and contribute to risk management plans and periodic safety reports
• Communicate safety findings to prescribers, patients and payers and maintain cross-functional governance
• Navigate the advanced matrix structure and manage multiple activities with priority setting
Responsabilidades
• 6+ years of relevant experience in Patient Safety and/or Clinical/Drug Development in at least 3 of: safety strategy for early/late-phase development, post-marketing surveillance, xqbhyrx MAA/BLA safety sections, periodic safety reports, risk management plans, governance board interactions
• Good knowledge of PV regulations
• Ability to manage multiple activities simultaneously and work effectively in an advanced matrix structure
• Proficient in written and verbal English
• Experience with safety documentation for regulatory submissions and safety strategy development
• Preferred: strong knowledge of hematology and understanding of epidemiology
Requisitos principales
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📌 Associate Director Senior Patient Safety Scientist (Barcelona)
🏢 AstraZeneca
📍 Barcelona