FSP Pharmacovigilance Coordinator (Night Shift)

Overview

Coordinates pharmacovigilance and safety-support activities for global and domestic programs, including adverse events, protocol inquiries, committee coordination, documentation, and project administration.

What you'll do

• Coordinate review and tracking of protocol inquiries, adverse events, diagnostics, and Data Safety Monitoring Board data.
• Represent the DSMB/EAC Coordination Team at committee meetings and manage meeting logistics.
• Prepare contractual documents and coordinate internal and external approvals.
• Compile adjudication dossiers and submit follow-up requests to investigative sites.
• Coordinate project meetings, minutes, client-portal materials, training, and program files.
• Manage data entry, system reconciliations, expenses, translations, and project budgets.
• Answer hotline calls, support local-office activities, and train junior staff.

What you'll need

• At least 2 years of relevant experience, or equivalent education, training, and directly related experience.
• High or secondary school diploma or equivalent with relevant academic or vocational qualification.
• Strong problem-solving, analytical, organizational, and prioritization skills.
• Effective written, oral, interpersonal, and diplomatic communication skills.
• Excellent computer skills, including Microsoft Word, Excel, PowerPoint, and Access.
• Working knowledge of FDA regulations, ICH Good Clinical Practices, and applicable SOPs and WPDs.
• Strong attention to detail and ability to work independently under strict deadlines.

Details

• Remote role based in the Philippines.
• Standard Monday–Friday schedule with a night-shift designation.
• Office environment; occasional site travel may be required.