Benefit-Risk Excellence Lead (Sr PV Manager) - client-dedicated for 12 months
Core
Lead short- and mid-term projects to drive innovation and excellence in Benefit-Risk Assessment & Management (BRAMS), enhancing procedures and supporting digital transformation within signal detection and safety writing systems.
Role type
Sr IC Benefit-Risk Excellence Lead (Strategy & Transformation)
Builds
Process/SOP changes, system requirements, and project outcomes for signal detection and safety writing systems
Domain
Biopharmaceuticals / Pharmacovigilance / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
Signal detection, safety writing, risk management, global GCP/GVP regulations, change leadership, business analysis, stakeholder alignment, transformation planning
Preferred skills
Digital transformation (automation/AI), portfolio prioritization, workshop facilitation
Technologies
AI, automation tools
Responsibilities
Governance and operating model support, executive stakeholder alignment, transformation roadmap development, initiative escalation and risk management, business case review, business analysis and requirements gathering, reporting and visualization support
Seniority
Senior, hands-on IC with strategic oversight