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 Management Assistant supports the Quality Management team in ensuring that PrimeVigilance’s controlled procedures and training activities are managed in compliance with global regulations, legislation and PrimeVigilance requirements.

Key responsibilities:

• Supporting the administration, tracking and management of PrimeVigilance Controlled Procedures and related training
• Managing and administrating internal technical and periodic training programs for PrimeVigilance employees
• Reviewing and approving Access Requests to PrimeVigilance’s controlled systems
• Developing, maintaining and managing periodic Quality and Compliance reports (including metrics and trending)
• Managing and maintaining the PrimeVigilance Quality Management Control System

Key Responsibilities will include:

For the Client: May include but is not limited to the following:

• Production of quality and compliance metrics per client project and employee
• Review and approval of client access to PrimeVigilance controlled systems

For the Company: This may include but is not limited to:

• Support PrimeVigilance functional teams in providing reports, procedures or training records from the PrimeVigilance Quality Management Control System. Deviations, non-conformities, and issues
• May support PrimeVigilance functional teams or the Quality Operations team in recording and tracking deviations, non- conformities and issues - and resulting CAPA plans
• May act as subsystem administrator for the Quality Management Control System 
• On behalf of Quality Management, may approve access to PrimeVigilance Controlled Systems for employees and clients

• Very good English skills (both verbal and written, B2 at least)
• Good knowledge of MS Excel and MS Word
• Administrative experience
• Excellent organizational skills, ability to work under pressure with accuracy and meet tight deadlines
• A high degree of discretion dealing with confidential information
• Ability to manage multiple and varied tasks and prioritize workload with attention to detail
• Excellent interpersonal and communication skills
• interpersonal and communication skills

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   

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