Director, Global Patient Safety Surveillance
Core
Lead principal subject matter expert for the design, development, maintenance, and support of core Global Patient Safety (GPS) processes including signal detection, risk management, and aggregate reporting.
Role type
Senior IC principal scientist (pharmacovigilance/safety surveillance)
Builds
Risk Management Plans (RMPs), Developmental Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), and regulatory safety narratives
Domain
Pharmaceutical/Biotechnology, Oncology, Pharmacovigilance
Required skills
Global PV regulations (ICH, GxP), Safety risk management, Signal detection & management, Aggregate reporting, Regulatory compliance (GCP, GVP), Cross-functional leadership, Strategic planning
Preferred skills
Advanced safety data analytics, PV systems management, BLA/MAA experience, Regulatory interaction management
Technologies
PV systems, Regulatory reporting tools
Responsibilities
Lead core GPS processes (comparative benefit-risk, signal detection, risk management, aggregate reporting), Manage assigned safety processes and deliver required regulatory outputs, Provide expert consultation for regulatory reports and clinical study documents, Ensure European compliance with QPPV, Drive development of controlled documentation for PV quality systems, Ensure inspection readiness for global audits, Strategically influence and innovate safety capabilities, Create bespoke solutions for emerging safety challenges, Partner with cross-functional stakeholders and PV systems personnel
Seniority
Senior, hands-on IC with strategic influence