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Company Description

PrimeVigilance (part of Ergomed Group) is a specialized mid-size pharmacovigilance service provider established in 2008. We have achieved global organic growth year after year, with staff based across Europe, North America and Asia 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 devices.

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well‑being and mental health, and acknowledge that a healthy work‑life balance is critical to employee satisfaction and to nurture an environment for high‑quality client service.

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. They ensure that the project maintains compliance with global regulations, legislation, PrimeVigilance and client requirements.

Core Responsibilities

• Direct oversight of all client quality related activities for the project.
• Work closely with the Quality Management, Quality Assurance and Audit Management teams to ensure adherence to PrimeVigilance’s and the client’s Quality Management System.
• Collaborate with the Project Manager and Project Team to ensure seamless delivery of all aspects of the Quality Cycle.
• Manage a variety of clients, delivering work with limited input.
• Ensure the timely and complete training of employees within client projects.
• Create and maintain a project‑specific quality management plan for each assigned project.
• Review 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 guidelines, SOPs and Joint Operating Guidelines.
• 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 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 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 quality review on a sample of fully processed cases each month to ensure that quality standards are maintained.
• Ensure the project is inspection‑ready at all times.
• Act as the main point of contact for all audit related activities for the project; compile pre‑audit requests, host all client audits, coordinate all responses to audit findings and ensure completion of all proposed actions.
• Contribute to 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 and 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 communication skills
• Good IT skills

Additional Information

We prioritize diversity, equity, and inclusion by creating an equal‑opportunity 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. We believe our people are our greatest strength, leading to continued success on improving the lives of those around us.

We Offer

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language

Core Values

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships

Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application.

Seniority level

• Entry level

Employment type

• Full‑time

Job function

• Quality Assurance

Industries

• Pharmaceutical Manufacturing

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