FSP Pharmacovigilance Coordinator

• Provide contracted project coordination and safety support for global and domestic programs
• 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, including teleconference and face-to-face meetings
• Coordinate meeting logistics and assist with facilitation
• Liaise with internal and external parties to implement projects
• Prepare and coordinate Confidentiality Disclosure Agreements, Letters of Intent, and Member Agreements
• Compile adjudication dossiers and submit follow-up to investigative sites
• Coordinate project meetings, draft minutes, post blinded and unblinded materials to client portals, and distribute them to project teams
• Manage project-specific training and program-file setup, maintenance, and archival
• Ensure pharmacovigilance programs remain audit ready
• Identify and redact subject identifiers, retrain sites, and escalate recurring issues to Data Privacy
• Enter data into internal/external databases, tracking systems, and budget management systems
• Perform system reconciliations to identify issues affecting project timelines
• Oversee expenses and manage translations within budget parameters
• Answer incoming hotline calls and coordinate department functions
• Provide training to junior staff

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Technical positions may require a certificate
• At least 2 years of previous experience, or comparable knowledge, skills, and abilities
• Strong problem-solving skills
• Ability to work independently with minimal supervision
• Ability to build strong relationships
• Ability to analyze project-specific data/systems for accuracy and efficiency
• Ability to communicate respectfully and diplomatically with clients, management, project team members, and internal staff
• Effective oral, written communication, and interpersonal skills
• Excellent computer skills, including MS Office (Word, Excel, PowerPoint, Access)
• Ability to prioritize and perform multiple tasks under strict deadlines
• Strong attention to detail and accuracy
• Ability to maintain a positive and professional demeanor in challenging circumstances
• Flexibility to reprioritize workload according to changing project timelines
• Knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and organizational/client SOPs and WPDs for clinical and non-clinical project implementation, execution, and closeout
• Ability to support local-office activities that cannot be performed elsewhere
• Potential ability to work long, varied hours when required

• Fully remote work mode
• Standard Monday–Friday work schedule
• Potential travel to site locations on rare occasions
• Training opportunities for junior staff