Pharmacovigilance Project Manager

Manage client or project specific PSS processes for products including drugs and devices, overseeing adverse events and safety reporting. Provide leadership and management of global or regional projects, ensuring communications and processes are harmonized.

Responsibilities:

• Monitor and manage workflow for assigned projects to ensure deadlines are met and compliant safety reporting is achieved.
• Make decisions regarding adverse event reporting within project guidelines.
• Work closely with clinical operations and project management groups to ensure PSS activities meet regulatory and contractual requirements.
• Oversee receipt and processing of adverse event reports, including entry into safety databases and tracking systems.
• Review adverse events for completeness, accuracy, and appropriateness for expedited reporting.
• Write patient narratives and code adverse events using MedDRA.
• Determine expectedness/listedness against the appropriate label.
• Identify clinically significant information missing from initial reports and ensure its collection.
• Ensure case receives appropriate medical review and prepare follow-up correspondence.
• Process expedited safety reports swiftly and appropriately within required timelines.
• Report endpoints to clients, regulatory authorities, and investigators within study specified timelines.
• Execute routine quality review of adverse event reports and aggregate reports.
• Complete triage, distribution checklist, and quality review of all ESRs.
• Provide oversight and management of EudraVigilance activities.
• Maintain a strong understanding of Fortrea's safety database conventions and system functionality.
• Prepare Safety Management Plans, Reconciliation Plans, and other safety specific plans.
• Provide oversight and/or preparation of timely pharmacovigilance reports.
• Monitor and manage project deliverables regarding contract assumptions and identify out-of-scope work or potential budget overruns.
• Contribute to the generation and review of Time and Cost Estimates for PSS business.
• Generate monthly status and project-specific reports.
• Attend client meetings and liaise with clients as needed.
• Provide PSS project training for assigned projects.
• Prepare and participate in audits.
• Maintain files regarding adverse event reporting requirements in all countries.
• Manage the review of cumulative safety data for submission to DSMBs, regulatory authorities, or clients.
• Manage the set-up of and provision of data to Safety Committees / Drug Safety Monitoring Boards.
• Work with Data Management or clients on reconciliation of safety databases.
• Contribute to the development and/or review of Clinical Trial Protocols and Adverse Event Reporting forms.
• Prepare and deliver safety presentations.
• Maintain a comprehensive understanding of PSS SOPs, Work Instructions, guidance documents, and directives.
• Possess knowledge of CDS procedural documents impacting safety.
• Contribute to the development of departmental Work Instructions and Standard Operating Procedures.
• Provide support and training for team members.
• Act as a mentor to less experienced colleagues.
• Supervise workloads and individual performance of more junior team members.
• Build and maintain good drug safety relationships across functional units.
• Demonstrate role-specific competencies and company values consistently.
• Financial authority as it relates to projects.
• All other duties as needed or assigned.