Experteer Overview
La siguiente información ofrece un resumen de las habilidades, cualidades y cualificaciones necesarias para este puesto.
In this role you will lead safety data review and strategy for complex products, collaborating with the Global Safety Physician and PV scientists. You will author safety inputs for regulatory documents and lead safety discussions with cross-functional teams and Safety Committees. You’ll drive proactive pharmacovigilance, risk management planning, and strategic safety input for regulatory submissions. You will mentor junior staff and ensure high-quality safety deliverables across development and marketed products. This opportunity offers a chance to shape patient safety strategies within a global pharma leader.
Compensaciones / Incentivos
• Lead proactive pharmacovigilance and risk management planning for complex products, including RSIs, REMS, and GAPs
• Guide safety activities for cross-functional development and/or marketed products
• Provide safety expertise to Investigator Brochures, Protocols, Informed Consents, and Clinical Study Reports




• Act as Safety Strategy and Management Team Leader for large or complex projects
• Present complex safety data to SIRC and coordinate with GSP and stakeholders
• Collaborate with GSP and Clinical teams to author Reference Safety Information (RSI) for complex products
• Contribute strategic input and oversight to periodic regulatory documents (PBRERs, PSURs, DSURs)
• Support regulatory submissions strategy for new products/indications (NDA/BLA, MAA)
• Participate xqbhyrx in negotiations on PS components of external contracts to ensure quality
• Train and mentor junior PV team members
Responsabilidades
• Life sciences/pharmacy/nursing degree with significant Patient Safety/Drug Development experience (7+ years)
• Fluent in written and spoken English
• Advanced knowledge of PV regulations
• MD/MSc/PhD in scientific discipline preferred
• Intermediate understanding of epidemiology preferred
Requisitos principales
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📌 Associate Director, Senior Patient Safety Scientist Oncology (Barcelona)
🏢 AstraZeneca
📍 Barcelona