Patient Safety Risk & Signal Management Product Lead
Core
Lead the technology strategy and product delivery for enterprise safety platforms (NGSMS, ORBIT) to support global pharmacovigilance operations, signal detection, benefit-risk evaluation, and risk management planning.
Role type
Associate Director, Product Lead for Patient Safety Risk & Signal Management
Builds
Scalable, compliant, and data-driven safety solutions for global regulatory obligations and proactive patient safety monitoring
Domain
Biopharmaceuticals / Pharmacovigilance / Regulated Technology
Required skills
Pharmacovigilance processes, Signal Detection, Signal Management, Benefit-Risk Assessment, Risk Management Planning (RMP), Aggregate Reporting, Safety Surveillance, ICH E2B/E2C guidelines, GVP Modules, FDA/EMA regulations, Computer System Validation (CSV), GxP compliance, NGSMS, ORBIT, API integration, Cloud platforms (AWS/Azure), Data analytics architectures, DevOps, CI/CD, Tableau, Spotfire
Preferred skills
Pharmacovigilance certifications, Agile/Product Management certifications, Cloud Technology certifications, IT Service Management certifications
Technologies
NGSMS, ORBIT, AWS, Azure, Tableau, Spotfire
Responsibilities
Define and implement strategic product roadmap for Risk & Signal Management platforms; Lead technology strategy and platform evolution for NGSMS and ORBIT; Drive product modernization leveraging automation, AI/ML-enabled analytics, and workflow orchestration; Provide technical leadership for signal detection, triage workflows, and aggregate safety data analysis; Lead and mentor a team of IT professionals and vendor partners; Act as a trusted advisor to senior leadership on technology strategy
Seniority
Senior, strategic leadership & hands-on product/technology SME