Vaccines Safety Sciences Lead
Core
Leads global pharmacovigilance (PV) safety sciences functions, ensuring regulatory compliance, managing safety data analysis, and overseeing PV system implementation for biotherapeutics.
Role type
Senior leadership pharmacovigilance safety sciences lead
Builds
Global PV systems, safety reports, and regulatory documentation for biotherapeutics
Domain
Life sciences / Pharmacovigilance / Regulatory Affairs
Required skills
Pharmacovigilance regulations, GxP guidelines, safety data analysis, regulatory inspections, CAPA management, SOP development, project management, data visualization, process optimization
Preferred skills
Medical evaluation of adverse events, new drug application safety updates, IT solution implementation, cross-functional leadership
Technologies
PV software applications, data visualization tools, regulatory reporting systems
Responsibilities
Manage PV functions and compliance with GxP and international regulations; oversee PV legislation evolution and system implementation; establish and maintain regulatory documents like PSMF; lead signal detection and safety data analysis; support regulatory inspections and audits; develop advanced analytical outputs for safety decision-making; provide management direction to direct reports; contribute to study and post-marketing safety activities; translate business requirements into technical solutions; assist in preparing safety updates and regulatory reports.
Seniority
Senior, hands-on IC with leadership responsibilities
