Quality Assurance Coordinator

Introduction 

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

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. 

Come and join us in this exciting journey to make a positive impact in patient’s lives.  

The Quality Assurance Coordinator role entails working in the Quality Department by providing organisational support to the Quality Assurance team, in project and/ or departmental related administrative tasks, including compilation of Quality Assurance related activities, tracking and retrieval, planning, coordinating, document organisation and filing.

Support for other QA activities could also be requested.

Role and Responsibilities

• The Quality Assurance Coordinator will support Quality Assurance activities within PrimeVigilance and will work with the functional teams and PrimeVigilance Subject Matter Experts (SMEs) to ensure services are delivered in line with contractual obligations or internal timelines.

• The Quality Assurance Coordinator will track all activities from project set up till closure described, including but not limited to:
  • Contracted Quality Consultancy projects
  • Contracted Quality Audit projects and CAPA management/ trending
  • Tracking the progress of internal projects and other quality initiatives

• Contracted Quality Consultancy and Auditing projects, coordinating
  • Communication with Business Development
  • Communication with pool of internal and external SMEs
  • • Tracking Legal obligations
    • Client Communication/ meeting minutes and client satisfaction
    • Invoicing assistance (retrieving from CMT, comparing with related contracts and actiTIME, as applicable
  • Administrative support
    • Supports with or contributes to departmental initiatives
    • Supports with presentation slides
    • Preparing document drafts and/ or final layout/ formatting
    • Organising meetings, preparing agendas and taking minutes
    • Assisting with employee on-boarding tasks and intro sessions
  • Other Supportive Responsibilities:
    • The Quality Assurance Coordinator will support the PrimeVigilance Senior Leadership team as needed.
    • Other QA support as needed.
  • Mentoring and training of new and more junior employees as required.

Educated to degree standard or appropriate equivalent work experience

• Understanding of the principles of Quality Assurance
• Experience of participating in quality activities
• Previous experience in the pharmaceutical and/or regulated industry in a quality setting

• Excellent communication (written and verbal) skills
• Organizational skills, including attention to detail and multitasking
• Planning and time management
• Technical skills
• Team working

Proactive and self-motivated

Why PrimeVigilance 

We prioritize diversity, equity, and inclusion by creating an equal opportunities 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. Why? because our people are our greatest strength leading to our 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 

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!  

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

We look forward to welcoming your application.