Benefit-Risk Excellence Lead (Sr PV Manager) - client-dedicated for 12 months
Core
Lead short- and mid-term projects to drive innovation and excellence within the Benefit-Risk Assessment & Management (BRAMS) function, enhancing procedures and supporting digital transformation (automation and AI) 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
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), workshop planning, reporting and visualization
Technologies
AI, automation tools, safety writing systems
Responsibilities
Governance and portfolio prioritization, executive stakeholder alignment, transformation roadmap development, initiative escalation and risk management, business case review, translation of business needs into system requirements, coordination between business and technology teams
Seniority
Senior, hands-on IC with strategic oversight