FSP Pharmacovigilance Coordinator (Night Shift)
Core
Coordinate pharmacovigilance safety support and project management for global and domestic clinical programs, managing adverse events, DSMB/EAC meetings, and contractual documentation.
Role type
Senior IC pharmacovigilance coordinator (safety administration)
Builds
Safety reports, adjudication dossiers, meeting minutes, and audit-ready program files
Domain
Clinical trials / Pharmacovigilance
Deliverable
client delivery
Required skills
Adverse event review and tracking, DSMB/EAC meeting coordination, contractual document preparation, data entry and system reconciliation, budget management, translation oversight, regulatory compliance (FDA/ICH), training delivery
Preferred skills
None stated
Technologies
MS Office (Word, Excel, PowerPoint, Access), internal/external databases, tracking systems
Responsibilities
Coordinate review of protocol inquiries and adverse events; represent organization at DSMB/EAC meetings; prepare and review contractual documents; compile adjudication dossiers; manage project files and training; perform data entry and system reconciliations; oversee expenses and translations; answer hotline calls; provide training to junior staff
Seniority
Mid-level, hands-on IC
