ERGOMED

Director

• Management and support of a team of Project Managers.
• Ensuring that all contracted activities performed on behalf of PrimeVigilance clients are delivered within budget and are on time with good quality and in compliance with the applicable regulatory requirements.
• Support project teams as PV expert on all contracted activities performed on behalf of PrimeVigilance clients, as necessary.
• Providing support to Business Unit Leads, Head of Global PM department and senior leadership management, as applicable, in other activities undertaken on behalf of the client and the company.
• Together with direct reports representing the client's and PrimeVigilance interests with the aim of keeping the agreed project scope
• Oversee management of changes to the project scope, project schedule and project costs, as applicable
• Maintaining good client relations and ensuring a consistently high quality of work for each client
• Being involved in issue escalation process, as applicable
• Understand client PV requirements and ensure service provided addresses all requirements
• Overseeing and monitoring Project set-up and maintenance activities planning; attending client meetings, as required
• Having an overview of deliverables to the clients
• Being involved in tasks to be delivered to the client, as applicable
• Oversight on all issues communication with clients
• Overseeing training of project teams
• Close cooperation with other PrimeVigilance and/or the client’s respective departments making sure contracted activities are delivered with high quality and within set timelines
• Assurance that all Primevigilance departments and respective personnel are familiar with the client and the project scope
• Review of client specific core documents (e.g. Joint operational guidelines, Safety management plan), as applicable
• Making sure invoices are prepared and sent on time
• Review project specific analysis, as needed
• Advising the client as requested or as appropriate in PV matters such as changes in regulations/guidance
• Providing the client with appropriate qualified resources to ensure their project is managed and handled effectively
• Overseeing the management of Quality Management System activities for the client, as required
• Making sure that quality standards applicable to the respective client are met
• Ensuring compliance with worldwide PV regulatory obligations; manage the process for Quality Events (QEs) and implement corrective and preventative action (CAPA).
• Participation in client audits and inspections
• Accountable for performance development and career management of Project Managers
• Manage performance and growth opportunities of Project Managers
• Provide soft skill and technical skill development to grow the PM team talent
• Develop career plan and provide coaching and mentoring.
• Communicate regularly with Project Managers to ensure their knowledge, understanding, and compliance with assigned project goals and departmental and corporate strategies and objectives.
• Support Business Development by assisting with resource planning.
• Engaging and coordinating with other line managers across the Project Management department
• Participate with the PrimeVigilance Senior Leadership Team to determine and operationalize corporate strategies and visions for the continued growth of PrimeVigilance.
• Participate to the development and implementation of recruiting, interviewing, and hiring strategies.
• Conduct new employee orientation and onboarding.
• Participate in project review meetings with senior management to ensure areas of development, training needs and coaching are aligned with the business needs.
• Monitor and/or manage assigned studies as needed according to all applicable SOPs, regulations, and guidelines.
• Assess Project Managers performance and liaise with Director of Projects where required.
• Assist project teams with coordination of study activities to ensure project deliverables meet sponsor deadlines and ensure all objectives and expectations are fulfilled.
• Work with all operational units to help investigate issues and promote effective resolutions.
• Establish strong professional relationships with colleagues by building trust, open communication, and managing day-to day operational issues.
• Provide excellent customer service to both internal and external clients; ensure the same from the Project Managers.
• Review and approve weekly timesheets for PrimeVigilance tasks.
• Review and approve requests from PMs for time off and support Project Management coverage plan.

PV Project Director

• Management and support of a team of Project Managers.
• Ensuring that all contracted activities performed on behalf of PrimeVigilance clients are delivered within budget and are on time with good quality and in compliance with the applicable regulatory requirements.
• Support project teams as PV expert on all contracted activities performed on behalf of PrimeVigilance clients, as necessary.
• Providing support to Business Unit Leads, Head of Global PM department and senior leadership management, as applicable, in other activities undertaken on behalf of the client and the company.
• Oversee management of changes to the project scope, project schedule and project costs, as applicable.
• Maintaining good client relations and ensuring a consistently high quality of work for each client.
• Being involved in issue escalation process, as applicable.
• Understand client PV requirements and ensure service provided addresses all requirements.
• Overseeing and monitoring Project set-up and maintenance activities planning; attending client meetings, as required.
• Having an overview of deliverables to the clients.
• Being involved in tasks to be delivered to the client, as applicable.
• Oversight on all issues communication with clients.
• Overseeing training of project teams.
• Provide soft skill and technical skill development to grow the PM team talent.
• Support Business Development by assisting with resource planning.
• Monitor and/or manage assigned studies as needed according to all applicable SOPs, regulations, and guidelines.
• Establish strong professional relationships with colleagues by building trust, open communication, and managing day-to day operational issues.
• Provide excellent customer service to both internal and external clients; ensure the same from the Project Managers.
• Review and approve requests from PMs for time off and support Project Management coverage plan.

Compliance

• Act as Local Contact Person for Pharmacovigilance for the designated country
• Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates
• With the help of a senior member of the team, develop strategy and manage set up activities (Project Management Plan, joint operating procedures, POAs and core documents)
• Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures
• Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures
• Collect, review, track and maintain LCPs' CVs, job descriptions, training records, contact details and monthly reports
• Ensure correct training assignment to and training compliance by the LCPs
• Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS
• Provide support to proposal development and input to budgets, provide department representation to BD meetings as required
• Prepare client’s invoices and review/approve vendors’ project invoices
• Provide training, coaching and mentoring to junior members of staff
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery
• Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes
• Participate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as required
• Track LCPs' key performance indicators and prepare monthly summary reports
• Provide feedback on performance of vendors to aid their assessment
• Provide input to department / company initiatives and contribute to the design/review of SOPs/working practice/guidance.

Senior Specialist, Regulatory & PV Network

Research Analyst

• Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study
• Identifies the investigators and verifies that the investigator has adequate qualifications, resources, facilities, equipment and staff to conduct the clinical study throughout the study period
• Trains investigational site staff as necessary
• When applicable, supports preparation of regulatory and / or EC submissions
• Participates in mentoring/training of new staff as well as performing co-monitoring visits, to assess junior staff performance

Senior Clinical Research Associate

Data Scientist

• Responsible for database testing, query management, management of lab reference ranges, serious adverse event reconciliation, vendor data reconciliation and other tasks related to data management
• Perform validation of EDC Systems and associated DM reports or listings
• Manage and Create EDC user accounts
• Update and maintain DM documentation as directed by the Lead Data Manager (LDM) or Project
• Provide the PDM with status updates on tasks that are assigned
• Support the Lead Data Manager with all DM related close-out activities and DBL checklist (query resolution, final reconciliations, development of reports)

Data Manager – Expert in Programming, Developing EDC Systems

• Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables
• Perform quality control of regulatory intelligence screening of legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
• Provide regulatory strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures.
• Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures.
• Ensure compliance with company procedures, processes, training records, systems and any other tools
• Provide training, coaching and mentoring to junior members of staff.

Senior Specialist, Regulatory Intelligence and Analytics

• Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables
• Driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
• Perform quality control of regulatory intelligence screening of legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
• Provide regulatory strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures.
• Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures.
• Ensure compliance with company procedures, processes, training records, systems and any other tools.
• Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated.
• Monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS.
• Provide support to proposal development and input to budgets.
• Provide department representation to BD meetings as required.
• Provide training, coaching and mentoring to junior members of staff.
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
• Participate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as required.
• Provide feedback on performance of vendors to aid their assessment.
• Provide input to department / company initiatives and contribute to the design/review of SOPs/working practice/guidance.

Senior Manager, Regulatory Intelligence and Analytics

QA Engineer

• Ensures continuous quality improvement through effective management and oversight of Audits and Inspections
• Facilitates ongoing quality improvement measures through communication of audit & Inspection intelligence and compliance guidance/training
• Leads, educates, mentors, and develops the team within the function to ensure competence and confidence in developing to become subject matter experts
• Ensures that reporting, review and analysis of Findings from Audits and Inspection and CAPAs are performed efficiently and in compliance with global regulations, legislation and PrimeVigilance requirements
• Manages a team that manages audit and inspection findings and observations and their associated corrective and preventative action plans (CAPAs)
• Manages and maintains the electronic quality management system (EG-QMS) Audits module -CAPA Management
• Performs periodic trending of Findings across the company, providing insights into the potential causes of trends
• Fosters a culture of quality within the organization as led by members of the Quality Leadership Team
• Participates in audits and inspections, follow-up of findings and completion of client questionnaires and RFP/RFI
• Acts as a Subject Matter Expert and client point-of-contact for Quality
• Collaborates with operational personnel to ensure effective root cause analysis and writing/delivery of appropriate CAPA Plans
• Develops and delivers training on related topics

Senior Quality Assurance Manager

• Ensures continuous quality improvement through effective management and oversight of Audits and Inspections
• Leads, educates, mentors, and develops the team within the function to ensure their competence and confidence
• Ensures that reporting, review and analysis of Findings from Audits and Inspection and CAPAs are performed efficiently and in compliance
• Manages and maintains the electronic quality management system (EG-QMS) Audits module -CAPA Management
• Performs periodic trending of Findings across the company, providing insights into the potential causes of trends to operational and quality management
• Fosters a culture of quality within the organisation as led by members of the Quality Leadership Team
• Participates in audits and inspections
• Acts as a Subject Matter Expert and client point-of-contact for Quality
• Collaborates and guides operational personnel to ensure effective root cause analysis and writing/delivery of appropriate CAPA Plans
• Generates metrics on CAPA compliance
• Assists in the development, maintenance and management of mechanisms that assure ongoing monitoring and compliance with all applicable laws and regulations

Business Intelligence Analyst

• Responsible for Business Intelligence – development, deployment and maintenance of various business reports using business intelligence tools OAS.
• Capability to develop scripts for report validation and data verification.
• Contributes to achieving company´s goals and objectives.
• Works independently.
• Develop, deploy, and maintain business intelligence reports using BI tools such as Oracle Analytics Server and Oracle BI Publisher.
• Perform comprehensive testing and validation of custom BI reports to ensure data accuracy, system performance, and compliance with business and regulatory requirements.
• Manage periodic and aggregate reporting activities, including oversight and/or execution of database reports and outputs.
• Implement and maintain data quality management processes to ensure data integrity, consistency, and suitability for reliable reporting and analytics.
• Provide support for database setup and configuration in collaboration with IT and safety systems teams.
• Assist in the validation of computerized systems to ensure compliance with organizational and regulatory requirements.
• Support data migration activities between databases while ensuring data integrity and accuracy.
• Prepare and maintain controlled documentation related to data management and database processes.
• Manage and maintain long-term client engagements, ensuring effective communication and delivery of reporting and data management services.

Associate PV Business Intelligence Expert – OBIEE, OAS, BI Publisher Experience

Project Manager

• Acting as the primary contact point for project-related matters
• Managing client’s expectations to make sure the client is satisfied with services of PrimeVigilance
• Preparing project scope and objectives based on the signed agreement between the client and PrimeVigilance
• Project activities planning, including deadlines and interim milestones
• Reporting for the client and the PrimeVigilance management, e.g., preparation of Monthly reports, serving as basis for invoicing

Pharmacovigilance Project Manager – Senior PV Project Manager

• Develop, deploy, and maintain business intelligence reports using BI tools such as Oracle Analytics Server and Oracle BI Publisher.
• Perform comprehensive testing and validation of custom BI reports to ensure data accuracy, system performance, and compliance with business and regulatory requirements.
• Manage periodic and aggregate reporting activities, including oversight and/or execution of database reports and outputs.
• Implement and maintain data quality management processes to ensure data integrity, consistency, and suitability for reliable reporting and analytics.
• Provide support for database setup and configuration in collaboration with IT and safety systems teams.
• Assist in the validation of computerized systems to ensure compliance with organizational and regulatory requirements.
• Support data migration activities between databases while ensuring data integrity and accuracy.
• Prepare and maintain controlled documentation related to data management and database processes.
• Manage and maintain long-term client engagements, ensuring effective communication and delivery of reporting and data management services.

Associate PV Business Intelligence Expert – OBIEE, OAS, BI Publisher

• Manages ICSR Management Unit for assigned staff and ensures all unit-relevant activities are delivered within agreed extent
• Contributes to achieving company´s goals and objectives
• Performs project budget reviews, and provides support to, and management of, the ICSR leads
• Independent analysis of workload, productivity and utilization of resources and their appropriate redistribution
• Coordination with other departments for all activities related to the ICSR Management Unit
• Managing the assigned ICSR Management Unit effectively
• Ensuring adequate resources within the ICSR project teams to achieve the maximum level of productivity and utilisation
• Setting productivity targets for ongoing projects and reviewing proposed target updates as required
• Defining the appropriate reallocation of resources in ICSR Management Unit
• Managing ICSR Leads/Line Managers to ensure all employees are adequately utilised and productive
• Notifying the Resourcing department about the need for additional resources for assigned project teams
• Proposing the necessary changes within the project team processes to ICSR leadership
• Finding solutions and introducing best practices to increase productivity and utilization within the ICSR Management Unit
• Training and mentoring of ICSR Line Managers and senior staff
• Preparing various analyses and reports
• Reviewing budgets and resource allocations for all new projects and new scope of work for existing projects

Director of ICSR, Pharmacovigilance

• The Senior Quality Assurance Manager ensures continuous quality improvement through effective management and oversight of Audits and Inspections.
• Facilitates ongoing quality improvement measures through communication of audit & Inspection intelligence and compliance guidance/training.
• The Senior Quality Assurance Manager leads, educates, mentors, and develops the team within the function to ensure their competence and confidence in developing to become subject matter experts.
• The Senior Quality Assurance Manager ensure that reporting, review and analysis of Findings from Audits and Inspection and CAPAs is performed efficiently and in compliance with global regulations, legislation and PrimeVigilance requirements
• Leads a team which manage audit and inspection findings and observations and their associated corrective and preventative action plans (CAPAs)
• Manages and maintains the electronic quality management system (EG-QMS) Audits module -CAPA Management.
• Performs periodic trending of Findings across the company, providing insights into the potential causes of trends to operational and quality management.
• Fosters a culture of quality within the organisation as led by members of the Quality Leadership Team.
• Participates in audits and inspections, including document request provision, front and back-room activities, and follow-up of audit and inspection findings and completion of client questionnaires and RFP/RFI.
• Acts as a Subject Matter Expert and client point-of-contact for Quality including attendance at operational and quality governance meetings.
• Collaborates and guides operational personnel to ensure effective root cause analysis and writing/delivery of appropriate CAPA Plans and develops and delivers training on these topics and other quality topics.
• Generates metrics on CAPA compliance
• Assists in the development, maintenance and management of mechanisms that assure ongoing monitoring and compliance with all applicable laws and regulations including but not limited to EU GVP, US FDA CFRs, JMPA and ICH-E6.

• Acting as the primary contact point for project-related matters
• Managing client’s expectations to make sure the client is satisfied with services of PrimeVigilance, and that the work PrimeVigilance delivers meets, or even exceeds, the clients’ expectations.
• Preparing project scope and objectives based on the signed agreement between the client and PrimeVigilance.
• Project activities planning, including deadlines and interim milestones
• Reporting for the client and the PrimeVigilance management, e.g., preparation of Monthly reports, serving as basis for invoicing.