Associate Director, Patient Safety Scientist

Experteer Overview

You will author and shape safety documents and manage Reference Safety Information to ensure regulatory readiness. Your leadership will focus on delivering patient-centric safety outcomes while operating at pace in a dynamic environment.

• Lead safety strategy and risk management planning for assigned products, defining global risk management scope.
• Represent Patient Safety on cross-functional development and commercial teams to inform program strategy with safety insights.
• Assess safety signals across trials, post-marketing, literature, and epidemiology; translate findings into actions.
• Present issues to governance bodies and lead data-driven safety discussions for oversight.
• Create and contribute to periodic safety documents (PBRERs, PSURs, DSURs) with regulatory readiness in mind.
• Develop and maintain Reference Safety Information for development products with clinical colleagues.
• Support regulatory submissions by contributing to safety sections and coordinating with global safety leads.
• Communicate safety concepts clearly at external meetings to diverse stakeholders.
• Ensure third-party agreements uphold Patient Safety quality and regulatory alignment.
• Build capability by training team members in safety tools and processes.

• Life sciences/pharmacy/nursing degree with demonstrated Patient Safety and/or Clinical/Drug Development experience.
• Intermediate knowledge of pharmacovigilance regulations.
• Fluent in written and spoken English.

•