FSP Pharmacovigilance Coordinator
Core
Coordinate project logistics, safety documentation, and data management for global and domestic clinical trials, focusing on adverse events and Data Safety Monitoring Boards.
Role type
Senior IC pharmacovigilance project coordinator
Builds
Clinical trial safety programs and regulatory compliance documentation
Domain
Pharmaceuticals and biotechnology clinical trials
Deliverable
client delivery
Required skills
Adverse event review and tracking, Data Safety Monitoring Board (DSMB) coordination, Contractual document preparation, Adjudication dossier compilation, Project meeting facilitation, Data entry and system reconciliation, Budget and expense management, Regulatory compliance knowledge (FDA, ICH GCP)
Preferred skills
Training junior staff, Site retraining and identifier redaction, Translation coordination
Technologies
MS Office (Word, Excel, PowerPoint, Access), Internal/external databases, Tracking systems
Responsibilities
Coordinate timely review of protocol inquiries and adverse events; Represent DSMB/EAC teams at global and domestic committee meetings; Prepare and review contractual documents (CDAs, LOIs); Compile adjudication dossiers and submit to investigative sites; Manage project training and file archival; Perform data entry and system reconciliations; Oversee expenses and translations; Answer hotline calls and coordinate department functions.