Company Description
We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.
PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.
We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Job Description
The Client Quality Officer, is primarily responsible for the implementation and maintenance of the quality system and training for their assigned client projects. Thus, ensuring that the project maintains compliance with global regulations, legislation, PrimeVigilance and client requirements.

Core responsibilities

• The Client Quality Officer will have direct oversight of all client quality related activities for their project. They will work closely with the Quality Management, Quality Assurance and Audit Management teams to ensure all aspects of PrimeVigilance’s and the Clients Quality Management System are being adhered to by the project. They will work closely with the Project Manager and Project Team to ensure seamless delivery of all aspects of the Quality Cycle.
• The Client Quality Officer will be expected to manage a variety of clients and would be expected to deliver work with of limited input.
• The Client Quality Officer will ensure the timely and complete training of employees within client projects.
• The Client Quality Officer will create and maintain a project specific quality management plan for each of their assigned projects.
• Review the weekly and monthly regulatory intelligence reports and assess impact on designated projects.
• Ensure all project related procedures are aligned and comply with global Pharmacovigilance regulations and guideline. SOPs and Joint Operating Guideline.
• Review and contribute to all project related procedural documentation to ensure that all activities within the scope of work are supported by fully implemented SOPs or other documentation.
• Ensure that all resources on the project are sufficiently qualified and that all project team members keep their CV, JD and training records up to date.
• Ensure that any necessary Business Continuity Plans (BCP) and Disaster Recovery Plans (DRP) are in place for project activities and systems and that such plans are tested regularly.
• Review and approve access requests to controlled systems (PACS) used for the project.
• Ensure that all backup, recovery logs and audit trails for project-related systems are regularly reviewed.
• Create and maintain a project specific training plan and training matrix, in conjunction with the Project Manager.
• Review and approve all project specific training materials created by PrimeVigilance.
• Monitor timely completion of training by project team, review competency based tests and sign off team members for live work.
• Gather, review and monitor project specific metrics and KPIs. Identify any issues or trends and ensure that they are addressed in a timely manner.
• Author quality and compliance sections of the project monthly report.

• Perform final time quality review on a sample of fully processed cases each month to ensure that quality standards are maintained.

  Ensure that project is inspection ready at all times.

• Act as the main point of contact for all audit related activities for the project and work closely with the Audit Management team to compile pre-audit requests, host all client audits, coordinate all responses to audit findings and ensure completion of all proposed actions.

  Contribute to any risk assessment activities performed by the Quality Assurance team for the project.

• Work with project team members to ensure that deviations are reported appropriately providing support with root cause analysis, categorisation.

• Ensure that appropriate corrective and preventative actions and effectiveness assessments are proposed.
• Manage all project related deviations and CAPAs to ensure timely completion.

QUALIFICATIONS

• Life Sciences degree
• Strong previous pharmacovigilance experience including quality and compliance experience within a GxP environment
• Good organisational skills, attention to detail and excellent communications skills
• Must have leadership qualities (Line Management experience is desirable)
• Good IT skills
  Additional Information
  We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
  To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

• The Client Quality Officer will have direct oversight of all client quality related activities for their project. They will work closely with the Quality Management, Quality Assurance and Audit Management teams to ensure all aspects of PrimeVigilance’s and the Clients Quality Management System are being adhered to by the project. They will work closely with the Project Manager and Project Team to ensure seamless delivery of all aspects of the Quality Cycle.
• The Client Quality Officer will be expected to manage a variety of clients and would be expected to deliver work with of limited input.
• The Client Quality Officer will ensure the timely and complete training of employees within client projects.
• The Client Quality Officer will create and maintain a project specific quality management plan for each of their assigned projects.
• Review the weekly and monthly regulatory intelligence reports and assess impact on designated projects.
• Ensure all project related procedures are aligned and comply with global Pharmacovigilance regulations and guideline. SOPs and Joint Operating Guideline.
• Review and contribute to all project related procedural documentation to ensure that all activities within the scope of work are supported by fully implemented SOPs or other documentation.
• Ensure that all resources on the project are sufficiently qualified and that all project team members keep their CV, JD and training records up to date.
• Ensure that any necessary Business Continuity Plans (BCP) and Disaster Recovery Plans (DRP) are in place for project activities and systems and that such plans are tested regularly.
• Review and approve access requests to controlled systems (PACS) used for the project.
• Ensure that all backup, recovery logs and audit trails for project-related systems are regularly reviewed.
• Create and maintain a project specific training plan and training matrix, in conjunction with the Project Manager.
• Review and approve all project specific training materials created by PrimeVigilance.
• Monitor timely completion of training by project team, review competency based tests and sign off team members for live work.
• Gather, review and monitor project specific metrics and KPIs. Identify any issues or trends and ensure that they are addressed in a timely manner.
• Author quality and compliance sections of the project monthly report.
• Perform final time quality review on a sample of fully processed cases each month to ensure that quality standards are maintained