LOCAL CASE INTAKE ADVISOR
Core
Manage the intake, processing, and communication of Individual Case Safety Reports (ICSRs) to safeguard patients and ensure regulatory compliance.
Role type
Local Case Intake Advisor (Pharmacovigilance)
Builds
Compliant patient safety reporting and regulatory response workflows
Domain
Healthcare / Pharmacovigilance / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmacovigilance knowledge, Good Pharmacovigilance Practice (GVP), Health Authority regulations knowledge, Vendor management, Attention to detail, Problem-solving
Preferred skills
Cross-functional collaboration, Lateral thinking, Training delivery
Technologies
Safety, regulatory, quality, HR, and commercial systems
Responsibilities
Intake and processing of ICSRs from various data sources, Responding to Health Authority queries, Managing product quality and security complaints, Reconciling pharmacovigilance data with partners, Mentoring local functions on safety issues, Overseeing external service providers
Seniority
Mid-level, hands-on IC