Client Quality Officer

Client Quality Officer
Viseu
Viseu, Viseu District, Portugal

Company Description

We are Prime
Vigilance (part of Ergomed Group), a specialised 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.

Prime
Vigilance 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, and invest in our staff through 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 for employee satisfaction and for delivering 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, ensuring that the project maintains compliance with global regulations, legislation, Prime
Vigilance and client requirements.

• Direct oversight of all client quality related activities for their project, working closely with the Quality Management, Quality Assurance and Audit Management teams to ensure adherence to Prime
  Vigilance’s and the client’s Quality Management System.
• Collaboration with the Project Manager and Project Team to ensure seamless delivery of all aspects of the Quality Cycle.
• Management of a variety of clients, delivering work with limited input.
• Ensuring timely and complete training of employees within client projects.
• Creation and maintenance of a project‑specific quality management plan for each assigned project.
• Review of weekly and monthly regulatory intelligence reports and assessment of impact on designated projects.
• Ensuring all project‑related procedures align with global Pharmacovigilance regulations and guidelines (SOPs and Joint Operating Guideline).
• Review and contribution 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.
• Ensuring all resources on the project are sufficiently qualified and that all project team members keep their CV, JD and training records up to date.
• Ensuring 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 approval of access requests to controlled systems (PACS) used for the project.
• Ensuring that all backup, recovery logs and audit trails for project‑related systems are regularly reviewed.
• Creation and maintenance of a project‑specific training plan and training matrix, in conjunction with the Project Manager.
• Review and approval of all project‑specific training materials created by Prime
  Vigilance.
• Monitoring timely completion of training by project team, reviewing competency‑based tests and signing off team members for live work.
• Gathering, reviewing and monitoring project‑specific metrics and KPIs to identify any issues or trends and ensuring timely resolution.
• Authoring quality and compliance sections of the project monthly report.
• Performing a 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 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 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 Gx
  P 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, because our people are our greatest strength, leading to our continued success in 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 patients’ lives. We look forward to welcoming your application.

Referrals increase your chances of interviewing at Prime
Vigilance by 2x.

Seniority Level

• Entry level

Employment Type

• Full‑time

Job Function

• Quality Assurance
• Pharmaceutical Manufacturing

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