Quality Management Associate

Company Description

We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially 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 becoming one of the global leaders in its fields. 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 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.

Job Description

The Quality Management Associate supports the Quality Management team in ensuring that PrimeVigilance’s controlled procedures, training activities and provision of systems’ access are managed in compliance with global regulations, legislation and PrimeVigilance requirements.

ROLE AND RESPONSIBILITIES

Key responsibilities:

• Supporting the administration, tracking and management of PrimeVigilance Controlled Procedures and related training

• Reviewing and approving Access Requests to PrimeVigilance’s controlled systems

• Managing and maintaining the PrimeVigilance electronic Quality Management System (e-QMS)

• Supporting PrimeVigilance e-QMS users

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

• Support audits and inspections on behalf of a client, as required by the Quality Assurance department, including the provision of CVs and Job Descriptions, procedures or training records from the PrimeVigilance e-QMS

For the Company:

This may include but is not limited to:

Quality oversight Audits, Inspections and internal Compliance Assessments

• Support PrimeVigilance functional teams in providing reports, procedures or training records from the PrimeVigilance e-QMS

• May supports the Quality Management team in obtaining metrics data for oversight of and reporting on PrimeVigilance’s e-QMS

• May develop, maintain and manage Quality and Compliance reports on behalf of the Quality Management team e-QMS

• Supports all PrimeVigilance functional teams in developing, managing and implementing PrimeVigilance Controlled Procedures and related training

• Supports and advises all PrimeVigilance functional teams in developing and managing project-specific documentation

• May act as subsystem administrator for the e-QMS

• May participate in efficiency projects to improve the use and management of the e-QMS

• On behalf of Quality Management, approves access to PrimeVigilance Controlled Systems for employees and clients Training

• May act as a Trainer for QMS-related training activities provided by the Quality Management department

Qualifications

Educated to degree standard (life science) or appropriate equivalent work experience

Previous experience in a Quality of Compliance-related role in any environment is desirable but not required

Prior experience with electronic Document Management or Training systems is desirable but not required

Additional Information

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.