Global Product Safety Science Lead
Core
Lead product-level safety ownership, signal detection, benefit-risk evaluations, and regulatory interactions for assigned pharmaceutical products.
Role type
Senior IC clinical safety science lead
Builds
Safety strategies, regulatory deliverables (PSURs, DSURs, RMPs), and benefit-risk assessments for product lifecycles
Domain
Biopharmaceuticals / Pharmacovigilance / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Signal detection and validation, benefit-risk assessment, regulatory strategy, cross-functional leadership, data synthesis, risk management
Preferred skills
Partner company collaboration, Health Authority presentation, regional PV requirements expertise
Technologies
Veeva Vault, SQL, Power BI, Spotfire, AI-enabled analysis tools
Responsibilities
Lead signal detection, evaluation, and escalation; chair Benefit Risk Teams; provide clinical safety input to study design and Target Product Profile; mentor safety team colleagues; support regulatory inspections and audits
Seniority
Senior, hands-on IC with strategic oversight
