Senior Director, Global Patient Safety - Rare Disease
Core
Lead global patient safety strategy and surveillance for obesity/metabolism products in various stages of development, serving as the primary point of contact for safety issues and managing benefit-risk assessments.
Role type
Senior Director, Global Patient Safety Lead
Builds
Safety profiles, safety strategies, and regulatory safety documents (DSURs, PSURs, RMPs) for assigned compounds.
Domain
Biopharmaceuticals / Pharmacovigilance / Rare Disease & Obesity
Required skills
Pharmacovigilance strategy, signal management, regulatory guideline application (FDA/EU/ICH), clinical document review, team leadership, cross-functional collaboration, SOP development, medical case review.
Preferred skills
Experience with advanced therapies (gene therapy), matrix environment navigation, mentoring junior scientists.
Technologies
GPS safety database
Responsibilities
Lead cross-functional Safety Management Team (SMT) activities, serve as delegate for Therapeutic Area Head, proactively develop safety strategies for non-compound specific activities, act as resource for complex ICSR medical review, participate in continuous improvement and SOP maintenance.
Seniority
Senior Director, strategic leadership & hands-on IC