・Responsible for the line-management of individuals within a team as well as a project team.
・Manage direct reports to ensure staff training records are up to date.
・Responsible for managing performance reviews and issues of direct reports.
・May manage individuals across multiple teams and will take on responsibility for cross department projects.
・Responsible for office management (schedules, desk assignments, business continuity planning, disaster recovery, etc.).
・May lead or assist with the management of PSS concerning project allocation and resourcing.
・General oversight for the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but not limited to:
-Entry of safety data onto adverse event 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 cases receive 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 the project personnel, if required, within study specified timelines
・General oversight for the management and processing of expeditable safety reports (ESRs). 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 ESR
-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 the project personnel, if required, within study specified timelines
・Complete triage, distribution checklist and quality review of all ESR for assigned projects.
・Execute routine quality review of AE reports and aggregate reports for other members of the group ensuring that case processing and data quality meet global regulatory compliance needs including audit support.
・Maintain awareness of the safety database conventions and system functionality.
・May prepare, but definitely provide oversight to the timely preparation of pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSR) of Serious Adverse Events (SAEs) and aggregate reporting.
・Responsible for the timely preparation and review of Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.
・Provide oversight and management of EudraVigilance activities for assigned projects.
・Provide oversight and/or perform signal detection and trend and pattern recognition activities, as required for assigned projects.
・Contribute to the generation and review of Time and Cost Estimates for PSS business.
・Work closely with the clinical operations and project management groups to ensure all drug safety activities are performed according to the regulatory and contractual requirements.
・Support the appropriate Clinical Data Management (CDM) team(s) in the reconciliation of SAEs across safety and trials databases.
・Contributes to the development and/or review of Clinical Trial Protocols, Case Report Forms and Adverse Event Reporting forms.
・Consistently responsible for assisting with the set-up of, and the provision of data to, Safety Committees / Drug Safety Monitoring Boards.
・Assist in the co-ordination of endpoint committees.