Associate Director Of Client Quality

hace 1 mes


Madrid, España Primevigilance A tiempo completo

.Company DescriptionWe 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.Job DescriptionThe 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. You will have responsibility for managing and leading the Client Quality Group.Responsibilities include:Oversight of Client Quality activities across all clients, working closely with the Senior Quality Director and the Vice President of Quality to ensure adherence to PrimeVigilance Quality Management System and the Clients Quality Management System.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.Oversight of Client Quality Group Activities:Ensure a process is maintained and monitored for reviewing weekly and monthly regulatory intelligence.Maintain SOPs and Joint Operating Guidelines.Support Client Quality Managers with authoring client-specific procedures and processes.Perform routine review of forecasted resources against actual resources for the group.Ensure all project resources are sufficiently qualified and that all project team members keep their CV, JD, and training records up to date.Maintain oversight and ensure necessary Business Continuity Plans (BCP) and Disaster Recovery Plans (DRP) are in place for projects and systems, tested regularly.Create and maintain a training matrix for the Client Quality Group.Provide training for the Client Quality Group as required.Review and monitor Client Quality Group metrics.Ensure that the Client Quality Group is audit and inspection ready at all times.Support Client audits and inspections as required



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