Associate Director Senior Patient Safety Scientist

Experteer Overview

Your work helps protect patients by turning safety data into actionable insights for prescribers, payers, and regulators. The opportunity sits in a high-impact oncology portfolio that pushes scientific boundaries in a results-driven, collaborative culture.

• Support safety strategy and regulatory safety requirements for assigned drug project(s)
• Aggregate, review, analyze and interpret safety data to inform decision-making
• Produce safety information for regulatory documents and submissions, including strategy and authoring
• Provide strategic safety input to regulatory documents and safety content of marketing authorization applications
• Collaborate with Global Safety Physician, PV scientists, and cross-functional teams (Clinical Project Teams, Global Regulatory Affairs, Global Commercial)
• Manage multiple activities in a matrix environment with effective prioritization
• Ensure compliance with PV regulations and quality standards
• Contribute to governance board interactions and cross-team communications

• Education: MD, MSc, PhD, or PharmD in a scientific field
• Minimum 6+ years of relevant experience
• Proven safety/clinical development experience in at least 3 areas: safety strategy for development programs, post-marketing surveillance, regulatory submissions (MAA/BLA) or PS reports and risk management
• Strong knowledge of PV regulations
• Ability to manage multiple activities simultaneously in an advanced matrix structure
• Proficient written and verbal English
• Preferred: knowledge of hematology and understanding of epidemiology

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