Associate Director, Patient Safety Scientist
AstraZeneca Barcelona
Experteer Overview
As Associate Director, Patient Safety Scientist, you will lead pharmacovigilance and risk management activities for designated products, collaborating with cross-functional teams to ensure patient safety insights inform development and regulatory decisions.You will author safety documents and contribute to regulatory submissions while guiding junior members and presenting findings at meetings. This role combines strategic safety input with hands-on data evaluation to shape the safety profile of medicines.
You will work in Barcelona, balancing office and remote work, and play a key part in maintaining rigorous safety standards.
Compensaciones / Beneficios- Lead proactive pharmacovigilance and risk management planning (Global Risk Management Plans) with GSP and others
- Represent Patient Safety on cross-functional project teams for development and marketed products
- Present safety information at external meetings
- Act as Safety Strategy and Management Team (SSaMT) lead for smaller or less complex projects
- Present issues to the Safety Information Review Committee (SIRC) and lead data evaluation discussions with SIRC Chair and stakeholders
- Produce accurate, fit-for-purpose safety evaluations in response to internal/regulatory requests
- Collaborate with GSP and Clinical to author RSI and coordinate meetings/timelines
- Evaluate clinical implications of safety data from pre-clinical, clinical, literature sources to manage patient risk
- Author/oversight for periodic regulatory documents (PBRERs, PSURs, DSURs)
- Contribute strategic input to regulatory submissions (NDA/BLA, MAA) with GSP and experts
- Contribute to PS components of third-party contracts to ensure quality and integrity
- Train junior team members in PS tools and systems
- Demonstrated Patient Safety and/or Clinical/Drug Development experience
- Intermediate knowledge of PV regulations
- Fluent in written and verbal English
- MD, MSc/PhD in scientific discipline, preferred
- Basic understanding of epidemiology data, preferred
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