Patient Safety Risk & Signal Management Product Lead
Core
Lead the technology strategy and product delivery for global Patient Safety platforms (NGSMS, ORBIT) focusing on Signal Management, Detection, Benefit-Risk Evaluation, and Risk Management Planning.
Role type
Associate Director, Product Lead for Patient Safety Risk & Signal Management
Builds
Enterprise safety platforms (NGSMS, ORBIT) and integrated pharmacovigilance solutions
Domain
Biopharmaceuticals / Pharmacovigilance / Regulated Technology
Deliverable
production ML models | product features
Required skills
Pharmacovigilance processes, Signal Detection & Management, Benefit-Risk Assessment, Risk Management Planning (RMP), ICH E2B/E2C guidelines, GVP Modules, FDA/EMA regulations, Computer System Validation (CSV), GxP compliance, NGSMS, ORBIT
Preferred skills
AI/ML-enabled analytics, Cloud-native architectures, Clinical development processes, MedDRA/WHO-Drug standards, Regulatory inspection support
Technologies
AWS/Azure, Tableau, Spotfire, APIs, CI/CD
Responsibilities
Define strategic product roadmap for Risk & Signal Management platforms, Lead technology strategy for NGSMS and ORBIT, Drive product modernization leveraging automation and AI/ML, Mentor IT professionals and vendor partners, Collaborate with Safety Science and Regulatory Affairs teams
Seniority
Senior, strategic leadership & hands-on product delivery