Senior Quality Specialist, Client Quality Management

Medicine moves forward here. So will you. 

At PrimeVigilance, patient safety is not one part of the job. It is why we exist. 

We are a global pharmacovigilance specialist. Our teams help clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post-marketing surveillance. Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that matters early and turning it into insight our clients can act on. 

That work takes curious minds, problem-solvers and experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America, Asia and Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from. 

If you want a role with real purpose, global reach and the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you. 

The Senior Quality Specialist, 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 Senior Quality Specialist 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 Senior Quality Specialist will be expected to manage a variety of clients and would be expected to deliver work with of limited input.

· The Senior Quality Specialist will ensure the timely and complete training of employees within client projects.

· The Senior Quality Specialist 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.