Global Product Safety Science Lead
Core
Lead signal detection, benefit-risk evaluations, and safety strategy for assigned pharmaceutical products across the lifecycle.
Role type
Senior IC product safety science lead
Builds
Regulatory safety deliverables (PSURs, DSURs, RMPs) and integrated safety strategies for product development
Domain
Biopharmaceuticals / Pharmacovigilance
Required skills
Pharmacovigilance expertise, global PV regulations knowledge, benefit-risk assessment, safety signal validation, regulatory document preparation, cross-functional team leadership, data analysis, stakeholder management
Preferred skills
Partner company collaboration, health authority presentation experience, regional PV requirements expertise
Technologies
Veeva Vault, SQL, Power BI, Spotfire
Responsibilities
Lead signal detection and escalation, chair Benefit Risk Teams, integrate safety into product development, mentor safety team members, support regulatory interactions and audits
Seniority
Senior, hands-on IC