Director, Global Patient Safety Sciences - Oncology
Core
Lead global patient safety strategy and activities for assigned oncology compounds, ensuring optimal support for drug development, operations, and commercialization.
Role type
Director, Global Patient Safety Sciences (Oncology)
Builds
Safety surveillance, signal management, benefit-risk assessments, and regulatory safety documents for oncology assets.
Domain
Life Sciences / Oncology / Pharmacovigilance
Required skills
Pharmacovigilance strategy, signal management, benefit-risk assessment, regulatory guideline application (FDA/EU/ICH), clinical document review, team leadership, SOP development, cross-functional collaboration.
Preferred skills
Oncology clinical experience, mechanism of action expertise.
Technologies
GPS safety database, DSURs, PSURs, RMPs, Investigator Brochures, Clinical Study Reports.
Responsibilities
Lead cross-functional Safety Monitoring Team activities, represent safety on strategic program teams, proactively develop safety strategies, act as resource for complex ICSR medical review, participate in continuous improvement and mentoring, apply critical analysis of regulatory guidelines.
Seniority
Director, strategic leadership & team management