Senior Quality Specialist, Client Quality Management

Company Description
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.

Job Description

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. 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 Good IT skills

Additional Information
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting. We are diverse in many ways, yet our values unite us.

Our values are how we work, not words on a wall. If they sound like you, you will feel at home here. Quality: we hold ourselves to the standard patients deserve.

Integrity and trust: we do the right thing, especially when it is hard. Drive and passion: we care about the outcome, because someone is waiting on it. Agility and responsiveness: we move quickly, because patients cannot wait.

Belonging: everyone is welcome, and every voice counts. Collaborative partnerships: we go further by going together. We look forward to welcoming your application.