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 (Rare Disease)
Builds
Safety surveillance plans, signal evaluation reports, periodic safety reports (DSURs, PSURs), and regulatory documents (ARM, RMP, SMP) for rare disease medicines.
Domain
Life Sciences / Pharmacovigilance / Rare Diseases
Required skills
Safety sciences operations leadership, signal detection and management, aggregate safety data analysis, SOP development, team building and succession planning, cross-functional coordination, regulatory compliance management, training curriculum development
Preferred skills
Global patient safety organization oversight, AI technologies integration, matrixed role leadership
Technologies
Safety Monitoring Team (SMT) tools, Safety Surveillance Plan (SSP) systems, Signal Evaluation Report (SER) platforms
Responsibilities
Develop common practices and templates to standardize safety execution; ensure compliance and quality management of safety activities; lead signal detection coordination and management processes; analyze aggregate safety data to identify emerging issues; drive training program development for staff; serve as main point of contact for strategy collaboration; collaborate with Clinical, Regulatory, and Med Affairs teams; build and scale a high-performing team.
Seniority
Director, hands-on leadership with team management
