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In this role you will lead pharmacovigilance and risk management activities for designated products, collaborating with the Global Safety Physician and PV scientists to review safety data and author safety documents. You will represent Patient Safety on cross-functional teams, present data at meetings, and drive safety strategies for regulatory submissions and periodic reports. You’ll mentor junior members and ensure timely, high-quality safety communications to internal and regulatory stakeholders. This position offers impact across development and marketed products within a mission-driven, inclusive environment.
Compensaciones / Ventajas
• Lead proactive PV and risk management planning for designated products
• Represent PS on cross-functional project teams for development and/or marketed products
• Present safety information at external meetings
• Serve as Safety Strategy and Management Team (SSaMT) leader for smaller projects




• Present issues to SIRC and lead data evaluation discussions with key stakeholders
• Produce fit-for-purpose safety evaluation documents in response to regulatory requests
• Collaborate with GSP and Clinical to author RSI and coordinate meetings
• Assess clinical implications of safety data to define drug safety profile and patient risk
• Author/provide strategic input for periodic regulatory documents (PBRERs, PSURs, DSURs)
• Contribute to regulatory submissions for new products/formulations/indications (NDA/BLA, MAA) in partnership with xghoner GSP and experts
• Contribute to PS component of third-party contracts to ensure quality and integrity
• Train junior team members in PS tools and systems
Responsabilidades
• Life sciences/pharmacy/nursing degree and experience in Patient Safety/Clinical/Drug Development
• Intermediate knowledge of PV regulations
• Fluent in written and verbal English
• MD, MSc/PhD in scientific discipline preferred
• Basic understanding of epidemiology data preferred
Requisitos principales
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📌 Associate Director,  Patient Safety Scientist (Barcelona)
🏢 AstraZeneca
📍 Barcelona