Assistant Manager- Japanese Language Local Case Intake Manager
Core
Lead a pharmacovigilance team to oversee the intake, processing, and reporting of adverse event cases (ICSRs) for designated markets, ensuring regulatory compliance and patient safety.
Role type
Assistant Manager, Pharmacovigilance (Case Intake)
Builds
Individual Case Safety Reports (ICSRs) and regulatory submissions for pharmaceutical products
Domain
Pharmaceutical industry / Pharmacovigilance
Deliverable
client delivery
Required skills
Pharmacovigilance expertise, regulatory compliance knowledge, team leadership, Health Authority engagement, SOP governance, data management, project management
Preferred skills
Experience with global patient safety systems (e.g., Argus), audit/inspection readiness, literature surveillance, after-hours intake processes, cross-functional collaboration
Technologies
Argus
Responsibilities
Lead and coach Local Case Intake Advisors; Ensure timely and accurate ICSR intake and submission; Coordinate responses to Health Authority queries; Conduct quality checks and drive corrective actions; Track operational metrics for continuous improvement; Maintain Pharmacovigilance System Master File; Implement local procedures and training; Plan business continuity coverage.
Seniority
Manager, hands-on leadership
