Project Manager Drug Safety - Medical device and IVD

Job Overview:

Manage ‘Client’ or ‘Project’ specific PSS processes associated with products ( drugs and devices) including the entire adverse events process. Manage and oversee the submissions of expedited and periodic safety reports to the regulatory agencies, ECs and investigators. Responsible for providing support to clients either as a support function to the client project groups or as stand-alone business. Provide all stakeholders, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. Perform financial oversight and audit/inspection support.

Summary of Responsibilities:

• Provide leadership and management of global or regional projects ensuring that communications and processes are harmonized for assigned projects.
• Monitor and manage the workflow for assigned projects to ensure all deadlines are met and compliant safety reporting in accordance with international reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team.
• Responsible for making decisions regarding adverse event reporting within the guidelines of each assigned project.
• Work closely with the clinical operations and project management groups to ensure all PSS activities are performed according to the regulatory and contractual requirements.

Provide oversight of the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial for assigned projects. This includes, but is not limited to:

• Entry of safety data onto adverse event database(s) and tracking systems.
• Review of adverse events for completeness, accuracy, and appropriateness for expedited reporting.
• Write patient narratives.
• Code adverse events accurately using MedDRA.
• Determine expectedness/listedness against appropriate label.
• Identifies clinically significant information missing from initial reports and ensures its collection.
• Ensure case receives appropriate medical review.
• Prepare follow-up correspondence consulting with the medical staff accordingly.
• Ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines.
• Reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Fortrea project personnel, if required, within study specified timelines.

Provide oversight of the management and processing of expedited safety reports (ESRs) for assigned projects. This includes, but is not limited to:

• Review and update adverse event databases and tracking systems.
• Review of adverse events for completeness, accuracy, and appropriateness for expedited reporting.
• Review of patient narratives.
• Review the coding of adverse events.
• Review of reporting of ESRs and endpoints to clients, regulatory authorities, ethics committees, investigators and Fortrea project personnel, if required, within study specified timelines.
• Execute and/or ensure routine quality review of adverse event reports and aggregate reports ensuring that case processing and data quality meet global regulatory compliance standards for assigned projects.
• Complete triage, distribution checklist and quality review of all ESRs for assigned projects.
• Provide oversight and management of EudraVigilance activities for assigned projects.
• Maintain a strong understanding of Fortrea ’s safety database conventions or client specific database conventions and system functionality.
• Provide oversight and/or perform signal detection and trend and pattern recognition activities, as required for assigned projects.
• Preparation of Safety Management Plans (SMPs), Reconciliation Plans, and other safety specific plans ensuring optimal efficiency.
• Provide oversight and/or preparation of timely pharmacovigilance reports for products and safety issues, including but not limited to Individual Case Summary Reports (ICSR) of Serious Adverse Events (SAEs) and aggregate reporting.
• Monitor and manage project deliverables regarding contract assumptions; identifying out of scope work or potential to run over budget.
• Contribute to the generation and review of Time and Cost Estimates for PSS business.
• Generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
• Attend client meetings and liaise with clients where appropriate.
• Consistently contributes to solving technical and/or operational problems of program/project members.
• Consistently proposes and executes innovative solutions which influence program/project direction.
• Provide PSS project training for assigned projects for PSS, Clinical Operations/Project Management, Client, and Investigators as required.
• Prepare and participate in audits, either by the client or a regulatory agency.
• Maintenance of files regarding adverse event reporting …