Night Shift

• Coordinate timely review of protocol inquiries, serious and non-serious adverse events, diagnostics and Data Safety Monitoring Board data
• Track required data and generate reports for clients, project teams and external vendors
• Represent the DSMB/EAC Coordination Team at global and domestic committee meetings via teleconference and face-to-face formats
• Coordinate meeting logistics and assist with facilitation alongside clients, board members, third-party vendors and project teams
• Prepare Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements
• Review contractual documents for accuracy and coordinate internal and external approvals
• Compile adjudication dossiers and create/submit follow-up to investigative sites
• Coordinate and facilitate project meetings; draft minutes and distribute blinded/unblinded materials through client portals
• Manage project-specific training and program file setup, maintenance and archival to keep pharmacovigilance programs audit-ready
• Identify and redact subject identifiers, retrain sites and escalate recurring issues to Data Privacy
• Perform data entry into databases, tracking systems and budget management systems
• Reconcile systems to identify issues that may negatively affect project timelines
• Oversee expenses and manage translations within budget parameters
• Answer incoming hotline calls and coordinate department functions
• Support activities performed by the local office that cannot be performed elsewhere
• Provide training to junior staff

Night Shift jobs in Philippines

FSP Pharmacovigilance Coordinator – Night Shift