Experteer Overview
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In this role you ensure safe medicines by guiding pharmacovigilance and risk management for designated products. You collaborate with integral safety and PV teams to author safety documents and regulatory inputs, and you lead safety data discussions with cross-functional partners. You will present safety analyses to internal and external stakeholders and can lead smaller projects as a Safety Strategy and Management Team member. You contribute to PSI content for regulatory reports and help shape development, regulatory submissions, and vendor contracts, while mentoring junior staff.
Compensaciones / Beneficios
• Lead proactive pharmacovigilance and risk management planning for designated products, co-operating with GSP and other experts
• Represent Pharmacovigilance on cross-functional project teams for development or marketed products
• Present safety data at external meetings
• Lead smaller/less complex projects as a Safety Strategy and Management Team (SSaMT) member




• Present issues to SIRC and lead data evaluation discussions with key stakeholders
• Produce accurate safety evaluation documents responding to regulatory inquiries
• Collaborate with GSP and Clinical teams to author RSI and track timelines
• Evaluate safety data across pre-clinical, clinical, and literature sources to define safety profiles and manage patient risk
• Author/input strategic content for periodic regulatory documents (PBRERs, PSURs, DSURs)
• Contribute strategic input to regulatory submissions for new products/formulations/indications (NDA/BLA, MAA) in xghoner partnership with experts
• Contribute to PS components of third-party contracts to ensure quality and integrity
• Train junior team members in PV tools and systems
Responsabilidades
• Life sciences/pharmacy/nursing degree with demonstrated Patient Safety/Clinical/Drug Development experience
• Intermediate knowledge of PV regulations
• Fluent in written and spoken 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