.Associate Director of Client Quality (Europe)Full-timeDepartment: PV QMWe are PrimeVigilance (part of Ergomed PLC), 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.Come and join us in this exciting journey to make a positive impact in patient's lives.The Associate Director of Client Quality, is primarily responsible for ensuring that quality activities conducted for PrimeVigilance's Clients are conducted to a high standard in line with global regulatory requirements, legislation and PrimeVigilance's Quality Management Systems and that the quality cycle is maintained across Client quality activities. You will have responsibility for managing and leading the Client Quality GroupResponsibilities include:Oversight ofClient Quality activities across all clients. Working closely with the Senior Quality Director and the Vice President of Quality to ensure all aspects of PrimeVigilance Quality Management Systemand the Clients Quality Management System are being adhered to by the Project.Ensure seamless delivery of all aspects of the Quality Cycle for Clients.Timely and complete training of the Client Quality Group.Create and maintain the structure and processes governing the activities of the Client Quality Group.Oversee all activities of the Client Quality Group, including but not limited to:Regulatory IntelligenceEnsure a process is maintained and monitored for review the weekly and monthly regulatory intelligence.SOPs and Joint Operating GuidelineSupport Client Quality Managers with authoring client specific procedures and processes.Human ResourcesPerform routine review of forecasted resources against actual resource for the group.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.Systems and FacilitiesMaintain oversight and ensure that any necessary Business Continuity Plans (BCP) and Disaster Recovery Plans (DRP) are in place for projects and systems as needed and that such plans are tested regularly.TrainingCreate and maintain a training matrix is maintain for the Client Quality Group
