Director, Global Patient Safety Sciences Delivery - Rare Disease
Core
Lead global patient safety sciences delivery operations for rare disease portfolios, ensuring compliant execution of safety surveillance, signal management, and aggregate reporting.
Role type
Director, Patient Safety Sciences Delivery
Builds
Safety surveillance plans, signal evaluation reports, and periodic safety reports (DSURs, PSURs) for rare disease products.
Domain
Life Sciences / Pharmacovigilance / Rare Diseases
Required skills
Safety sciences leadership, signal detection, aggregate safety data analysis, SOP development, team building, regulatory compliance, cross-functional coordination, training program development
Preferred skills
Global patient safety organization oversight, AI technologies, matrixed role leadership
Technologies
Safety Monitoring Team (SMT), Safety Surveillance Plan (SSP), Signal Evaluation Report (SER), ARM, RMP, SMP
Responsibilities
Develop common practices and templates for signal detection and safety document authoring; Ensure compliance and quality management of safety activities; Lead signal detection coordination and management processes; Analyze aggregate safety data to identify emerging issues; Support cross-functional coordination for benefit-risk assessments; Drive development of training programs and knowledge management repositories; Build and scale a high-performing team; Liaise with Safety Sciences Strategy and key interfaces (Clinical, Regulatory, Med Affairs).
Seniority
Director, hands-on leadership