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Company Description

We are PrimeVigilance (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 in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

PrimeVigilance provides top-tier support to pharmaceutical and biotechnology partners, maintaining long-lasting relationships and becoming a global leader in its field. We cover all therapy areas, including medical devices.

We invest in our staff by providing excellent training and development opportunities. We value employee experience, well-being, and mental health, recognizing that a healthy work-life balance is crucial for employee satisfaction and high-quality client service.

Job Description

The Client Quality Officer is primarily responsible for implementing and maintaining the quality system and training for assigned client projects, ensuring compliance with global regulations, legislation, PrimeVigilance, and client requirements.

Core Responsibilities

• Oversee all client quality-related activities for their project, working closely with Quality Management, Quality Assurance, and Audit Management teams to ensure adherence to systems and standards.
• Manage multiple clients and deliver work with limited input.
• Ensure timely and complete training of project employees.
• Create and maintain project-specific quality management plans.
• Review regulatory intelligence reports and assess impacts on projects.
• Ensure project procedures comply with pharmacovigilance regulations, SOPs, and guidelines.
• Review and contribute to procedural documentation.
• Verify project resources are qualified and training records are up-to-date.
• Ensure Business Continuity and Disaster Recovery Plans are in place and tested.
• Review access requests and audit logs for controlled systems.
• Develop and maintain training plans and matrices, review training materials, and monitor training completion.
• Monitor project metrics and KPIs, addressing issues proactively.
• Author quality and compliance sections of monthly reports.
• Perform final quality reviews on processed cases monthly.
• Ensure the project is inspection-ready at all times.

Act as the main contact for audit activities, coordinate responses, and facilitate audit readiness.

• Contribute to risk assessments and manage deviations and CAPAs, ensuring timely closure.

Qualifications

• Degree in Life Sciences
• Extensive pharmacovigilance experience, including quality and compliance in a GxP environment
• Strong organizational, communication, and attention-to-detail skills
• Leadership qualities; line management experience is desirable
• Proficient IT skills

Additional Information

We promote diversity, equity, and inclusion, fostering an environment where all backgrounds and genders can contribute and grow.

We emphasize working together with a human-first approach because our people are our greatest strength.

We Offer

• Internal training and career development opportunities
• Focus on personal and professional growth
• Supportive, friendly working environment
• Global collaboration with colleagues worldwide, with English as the company language

Our core values include Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, and Collaborative Partnerships.

Join us in making a positive impact on patients’ lives. We look forward to your application.

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