FSP Pharmacovigilance Coordinator – 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
• Coordinate meeting logistics and assist with facilitation
• Liaise with internal and external parties to implement projects
• Prepare and review Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements
• Coordinate internal and external contractual approvals
• Compile adjudication dossiers and submit follow-up to investigative sites
• Coordinate and facilitate project meetings, draft minutes, and distribute meeting materials
• Manage project training and program-file setup, maintenance and archiving
• Ensure pharmacovigilance programs remain audit ready
• Identify and redact subject identifiers, retrain sites and escalate recurring issues to Data Privacy
• Perform data entry in databases, tracking systems and budget management systems
• Perform system reconciliations and identify issues that may 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
• 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 comparable previous experience
• Equivalent combination of appropriate education, training and/or directly related experience may be considered
• 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
• Effective liaison and respectful, diplomatic communication 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
• Flexibility to reprioritize workload according to changing project timelines
• Working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and organizational/client SOPs and WPDs for non-clinical/clinical project implementation, execution and closeout

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