Director, Global Patient Safety Sciences - Oncology
Core
Lead global patient safety strategy, signal management, and regulatory compliance for oncology assets, serving as the primary point of contact for safety issues and representing the team on cross-functional strategic programs.
Role type
Director, Global Patient Safety Sciences (Oncology)
Builds
Safety surveillance systems, regulatory submissions (DSURs, PSURs, RMPs), and risk management plans for oncology drug assets.
Domain
Life Sciences / Oncology / Pharmacovigilance
Required skills
Pharmacovigilance strategy, signal management, regulatory guideline application (FDA/EU/ICH), clinical document review, team leadership, SOP development, benefit-risk assessment
Preferred skills
Oncology therapeutic area experience, complex ICSR review, cross-functional stakeholder influence
Technologies
GPS safety database, regulatory submission platforms
Responsibilities
Lead cross-functional Safety Monitoring Team activities, represent Global Patient Safety on committees (RSOC, IDMC, SPT), develop safety strategies for non-compound specific activities, act as subject matter expert for assigned compounds, mentor junior safety scientists, apply critical analysis of global pharmacovigilance regulations.
Seniority
Director, strategic leadership with hands-on technical oversight