【AstraZeneca】【GBS-PS】Local Case Intake Team Manager,Global Business Services
Core
Overseeing the local case intake process for Japan regulatory reporting, ensuring efficient and compliant handling of adverse event reports.
Role type
Team Manager, Pharmacovigilance
Builds
Individual Case Safety Reports (ICSRs) and regulatory submissions for Japan
Domain
Pharmaceutical industry, Pharmacovigilance
Required skills
Pharmacovigilance regulations, Team leadership, Health Authority interactions, KPI monitoring, SOP implementation, Audit readiness, Quality checks, Cross-functional collaboration, SLA management, Training and mentoring
Preferred skills
Higher Degree (MBA, PHD), Medical/Science background
Technologies
Argus
Responsibilities
Leading and managing a local case intake team, Overseeing the intake, processing, and reporting of Individual Case Safety Reports (ICSRs), Monitoring and analysing local case intake metrics, Staying updated on changes to local and global pharmacovigivance regulations, Participating in audits and inspections, Conducting quality checks on completed cases, Serving as a liaison between local and global levels, Ensuring timely submission of ICSR to local health authorities, Training and mentoring of staff on safety information
Seniority
Manager, hands-on leadership