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• Submission of expedited Serious Adverse Event (SAE) reports, Periodic reports, line listings and applicable safety information to clients, Regulatory Authorities, Ethics Committees, investigators, third party vendors, Partners, and ICON personnel, if required & as agreed with client during study set-up, within project specified timelines.
• Release of safety reporting intelligence for expedited and periodic reports, line listings, for Regulatory Authorities, Ethics Committees, and investigators within specified timelines.
• Maintain a comprehensive understanding of ICON’s safety reporting systems, processes, and conventions, as appropriate.
• Maintain a comprehensive understanding of ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), guidance documents and manuals associated with safety reporting.
• Perform oversight of assigned projects ensuring all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information or for the release of global safety reporting intelligence requirements.
• Operate in a lead capacity ensuring ownership and accountability of safety reporting activities or safety reporting intelligence on assigned projects.
• Ensure completion of all assigned project activities accurately and in accordance with ICON standards, regulatory requirements, and client contractual obligations.
• Serve as support to the Safety Reporting Group management in all aspects of departmental activities, including but not limited to quality and compliance metric review, finance tracking and oversight, project resource tracking, client engagement, training oversight and CAPA oversight as designated.
• Collaborate with various parties such as project team members, client contacts, investigators, adverse event reporters, and third-party vendors as applicable Build and maintain good relationships across functional units.
• Work within multiple databases. Maintenance of project information or Pharmacovigilance intelligence information with timely updates to the project or intelligence databases.
• Perform filing and quality control of documents submitted to the eTMF or agreed filing solution ensuring file readiness on assigned projects for audits or inspections.
• Prepare for and represent the department in audits and inspections as designated.
• Effectively coaches and mentors less experienced associates in all aspects of safety reporting or safety reporting intelligence and other work, as needed.
• Implement and coordinate routine project activities, including presentations at client or investigator meetings, responses to client, authorities, and other stakeholders; review of project requirements and maintenance activities; review, escalation of metrics; and budget considerations as assigned.
• Participate in client and internal meetings, representing the Safety Reporting department for the assigned projects as designated.
• Maintain understanding of applicable therapeutic areas and disease states as required.
• Travel (approximately 10%) domestic and/or international, as required.
• Perform other activities as identified and requested by management.