Lead GPV Professional, ICSR Conventions
Core
Lead GPV Professional ensuring regulatory compliance and inspection readiness for System Data Innovation (SDI) processes and Global Pharmacovigilance (GPV) conventions.
Role type
Senior individual contributor, regulatory compliance lead
Builds
Compliance frameworks, inspection readiness, SDI process improvements, SOPs/WIs
Domain
Biopharmaceuticals, Pharmacovigilance, Regulatory Affairs
Required skills
Biopharmaceutical/CRO industry experience, Health Authority inspection handling, Project Management, AI/Technical expertise, Veeva Vault Safety knowledge, English fluency
Preferred skills
None stated
Technologies
Veeva Vault Safety
Responsibilities
Manage SDI audits and inspections; Train SDI section members and LSOs/PV functions on SDI processes; Coordinate SDI risk cards, remediation plans, and deviations/CAPAs; Lead continuous improvement projects for GPV/patient safety; Design V-safe functionalities analysis and enhancements; Author SDI/GPV ICSR SOPs and WIs; Manage change control and gap assessments; Coordinate SDI training and knowledge management; Facilitate cross-functional synergy with ICSR Operations, Quality, Project Management, and Systems teams.
Seniority
Senior, hands-on IC