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
Deliverable
client delivery
Required skills
Pharmacovigilance knowledge, Health Authority regulations expertise, Vendor management, Data reconciliation, Literature search, Cross-functional collaboration, Problem-solving, Attention to detail
Preferred skills
None stated
Technologies
None stated
Responsibilities
Support end-to-end intake, review, assessment, processing, tracking, and reporting of ICSRs; Support timely responses to Health Authority queries; Perform data reconciliations and regulatory database screenings; Identify and route product quality and security complaints; Provide mentorship to local functions on issue and risk management; Support external service providers in meeting regulatory requirements; Undertake manual follow-up and maintain documentation; Maintain current knowledge of local regulatory requirements and product safety conditions.
Seniority
Individual Contributor, moderate scope and complexity