Director, Global Patient Safety Sciences - General Medicine
Core
Lead global patient safety strategy, signal management, and regulatory compliance for assigned compounds in general medicine.
Role type
Director, Global Patient Safety Sciences
Builds
Safety surveillance, signal management, and regulatory submissions for drug assets
Domain
Pharmaceutical / Pharmacovigilance
Deliverable
client delivery
Required skills
Pharmacovigilance strategy, signal detection and management, regulatory guideline application (FDA/EU/ICH), clinical document review, SOP development, team leadership, risk-benefit assessment
Preferred skills
Oncology clinical experience, mechanism of action analysis
Technologies
GPS safety database
Responsibilities
Lead cross-functional Safety Monitoring Team activities, represent safety on strategic program teams, develop safety strategies for non-compound specific activities, 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
