ERGOMED

Clinical Research

• Perform on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visits
• Ensure investigational site facilities and staff remain adequate for study conduct
• Identify investigators and verify their qualifications, resources, facilities, equipment, and staff
• Train investigational site staff as necessary
• Support preparation of regulatory and/or EC submissions when applicable

Clinical Research Associate II

Manager

• Provide support to activities undertaken by the project team on behalf of the client and company
• Line manage assigned ICSR staff
• Create and maintain project-specific KPIs for contracted ICSR activities
• Optimize procedures, trainings and other actions to increase ICSR team efficiency
• Propose process changes to the ICSR Operational Lead
• Manage ICSR deviations with support from the ICSR Operational Lead
• Review trackers and timesheet data and ensure accuracy
• Participate in ICSR processing and second-level quality control of cases
• Support other departments as approved and instructed by the ICSR Operational Lead
• Act as the assigned team subject matter expert and support other SMEs
• Support the RA & PV Network Department as needed
• Act as LCPPV for the specified country and PRLS for the designated language, as agreed with the line manager

Case Processing Manager, Team Lead

• Provide support to other activities undertaken by the project team on behalf of the client and company
• Line manage assigned ICSR staff
• Create and maintain project-specific KPIs for contracted ICSR activities
• Optimize procedures, trainings, and other actions to increase ICSR team efficiency
• Propose process changes to the ICSR Operational Lead
• Manage ICSR deviations with support from the ICSR Operational Lead
• Review trackers and timesheet data and ensure accuracy
• Participate in ICSR processing and second quality control of cases
• Support other departments as approved and instructed by the ICSR Operational Lead
• Act as the assigned team subject matter expert and support other SMEs
• Support the RA & PV Network Department as needed
• Act as LCPPV for the specified country and PRLS for the designated language, as agreed with the line manager

• Provide support to other activities undertaken by the project team on behalf of the client and the company
• Line manage assigned ICSR staff
• Create and maintain project-specific KPIs for contracted ICSR activities
• Optimize procedures, trainings, and other actions to increase ICSR team efficiency
• Propose process changes to the ICSR Operational Lead
• Manage ICSR deviations with support from the ICSR Operational Lead
• Review trackers and timesheet data and ensure accuracy
• Participate in ICSR processing and second quality control of cases
• Support other departments as approved and instructed by the ICSR Operational Lead
• Act as the assigned team subject matter expert and support other SMEs
• Support the RA & PV Network Department as needed
• Act as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country
• Act as the PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager

• Provide support to other activities undertaken by the project team on behalf of the client and the company
• Line manage assigned ICSR staff
• Create and maintain project-specific KPIs for contracted ICSR activities
• Optimize procedures, trainings, and other actions to increase ICSR team efficiency
• Propose process changes to the ICSR Operational Lead
• Manage ICSR deviations with support from the ICSR Operational Lead
• Review trackers and timesheet data and ensure accuracy
• Participate in ICSR processing and second quality control of cases
• Support other departments as approved and instructed by the ICSR Operational Lead
• Act as the assigned team subject matter expert and support other SMEs
• Support the RA & PV Network Department as needed
• Act as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country
• Take on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager

• Provide support to other activities undertaken by the project team on behalf of the client and the company
• Line manage assigned ICSR staff
• Create and maintain project-specific KPIs for contracted ICSR activities
• Optimize procedures, trainings, and other actions to increase ICSR team efficiency
• Propose process changes to the ICSR Operational Lead
• Manage ICSR deviations with support from the ICSR Operational Lead
• Review trackers and timesheet data and ensure accuracy
• Participate in ICSR processing and second quality control of cases
• Support other departments as approved and instructed by the ICSR Operational Lead
• Act as the assigned team subject matter expert and support other SMEs
• Support the RA & PV Network Department as needed
• Act as LCPPV for the specified country and PRLS for the designated language, as agreed with the line manager

• Provide support to other activities undertaken by the project team on behalf of the client and the company
• Line manage assigned ICSR staff
• Create and maintain project-specific KPIs for contracted ICSR activities
• Optimize procedures, trainings and other actions to increase ICSR team efficiency
• Propose process changes to the ICSR Operational Lead
• Manage ICSR deviations with support from the ICSR Operational Lead
• Review trackers and timesheet data and ensure accuracy
• Participate in ICSR processing and second quality control of cases
• Support other departments as approved and instructed by the ICSR Operational Lead
• Act as the assigned team subject matter expert and support other SMEs
• Support the RA & PV Network Department as needed
• Act as the LCPPV for the specified country and PRLS for the designated language, as agreed with the line manager

Project Manager

• Act as the primary contact point for project-related matters
• Manage client expectations to ensure client satisfaction and that delivered work meets or exceeds expectations
• Prepare project scope and objectives based on the signed client agreement
• Plan project activities, including deadlines and interim milestones
• Prepare reports for the client and PrimeVigilance management, including monthly reports used as a basis for invoicing

PV Project Manager

Associate

• Process Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures, client-specific requirements and timelines
• Perform ICSR follow-up activities
• Manage SAE/SUSAR activities, including unblinding, clinical trial reconciliation, protocol review and Safety Management Plan review
• Perform clinical and partner reconciliation
• Handle personal data protection activities
• Handle Product Quality Complaints and interact with Quality Assurance
• Interact with Medical Information
• Perform MedDRA and WHO coding
• Produce database outputs and reports, including monthly client reporting data
• Manage workflow and resources
• Support pharmacovigilance processes for PrimeVigilance and clients
• Perform tasks assigned to more junior positions as appropriate for a senior colleague
• Support the RA & PV Network Department as needed
• Act as LCPPV for a specified country and PRLS for a designated language, as agreed with the line manager

Senior Pharmacovigilance Associate

• Process Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures, client-specific requirements, and timelines
• Perform ICSR follow-up, including SAE/SUSAR management, unblinding, clinical trial reconciliation, protocol review, and Safety Management Plan review
• Perform clinical and partner reconciliation
• Handle personal data protection activities
• Handle Product Quality Complaints and interact with Quality Assurance
• Interact with Medical Information
• Perform MedDRA and WHO coding
• Produce database outputs and reports, including data for monthly client reporting
• Manage workflow and resources
• Support pharmacovigilance processes within PrimeVigilance and for clients
• Perform tasks assigned to more junior positions as appropriate for a senior colleague
• Support the RA & PV Network Department as needed
• Act as LCPPV for the specified country as agreed with the line manager
• Take on the PRLS role for the designated language as agreed with the line manager

• Process Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures, client requirements, and timelines
• Perform ICSR follow-up activities
• Manage SAE/SUSAR activities, including unblinding, clinical trial reconciliation, protocol review, and Safety Management Plan review
• Perform clinical and partner reconciliation
• Handle personal data protection activities
• Handle Product Quality Complaints and interact with Quality Assurance
• Interact with Medical Information
• Perform MedDRA and WHO coding
• Produce database outputs and reports, including data for monthly client reporting
• Support workflow and resource management
• Support ICSR-related pharmacovigilance processes for PrimeVigilance and clients
• Perform tasks assigned to more junior positions as applicable for a senior colleague
• Support the RA & PV Network Department as needed
• Act as LCPPV for a specified country when assigned
• Act as PRLS for a designated language when assigned

• Process Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures, client requirements, and timelines
• Perform ICSR follow-up activities
• Manage SAEs/SUSARs, including unblinding, clinical trial reconciliation, protocol review, and Safety Management Plan review
• Perform clinical and partner reconciliation
• Handle personal data protection activities
• Handle Product Quality Complaints and interact with Quality Assurance
• Interact with Medical Information
• Perform MedDRA and WHO coding
• Produce database outputs and reports, including monthly client reporting data
• Manage workflow and resources
• Support pharmacovigilance processes related to ICSR management within PrimeVigilance and for clients
• Perform tasks assigned to more junior positions, where applicable for a more senior colleague
• Support the RA & PV Network Department as needed
• Act as LCPPV for the specified country and PRLS for the designated language, as agreed with the line manager