Experteer Overview

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In this role you will lead safety data reviews and collaborate with the Integral Safety Physician to shape pharmacovigilance strategy for complex products. You’ll author safety input for regulatory documents and guide cross-functional teams through safety issues. You will present analyses to safety governance forums and drive international regulatory safety deliverables.

This position offers influence across development and lifecycle safety, supporting a mission-driven team focused on patient safety and regulatory excellence. You will engage with diverse stakeholders to advance safety science and risk management at scale.

Compensaciones / Beneficios

- Lead proactive pharmacovigilance and risk management planning for complex products, including safety aspects of global risk management strategies
- Steer safety activities within cross-functional project teams for developmental and marketed products
- Provide safety expertise for Investigator Brochers, Protocols, Informed Consents and Clinical Study Reports




- Serve as Safety Strategy and Management Team (SSaMT) Leader for large/complex projects
- Present safety data to the Safety Information Review Committee (SIRC) and drive data evaluation discussions with GSP and stakeholders
- Collaborate with GSP and Clinical representatives; author Reference Safety Information (RSI) for complex products
- Contribute strategically to periodic regulatory documents (PBRERs, PSURs, DSURs) and ensure timelines
- Lead regulatory submissions strategy for new products/formulations/indications (NDA/BLA, MAA) with cross-functional input
- Negotiate xugodme PS components of contracts to ensure quality of third-party arrangements
- Train and mentor junior team members in PV processes and analytic methodologies

Responsabilidades

- Life sciences/pharmacy/nursing degree with 7+ years of patient safety or clinical/drug development experience
- Fluent in written and spoken English
- Advanced knowledge of pharmacovigilance 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