Associate, Quality and Compliance Metrics

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

POSITION SUMMARY

The Associate, Quality Projects and Metrics, supports the Quality Projects and Metrics Team in

ensuring that PrimeVigilance’s Quality and Compliance Metrics are compiled, analyzed and reported in

compliance with global regulations, legislation and PrimeVigilance requirements.

ROLE AND RESPONSIBILITIES

The Associate, Quality Projects and Metrics will be responsible for all activities associated with the compilation, maintenance and management of the PrimeVigilance periodic Quality and Compliance Metrics Report. Activities include, but are not limited to:

• Ensuring that metrics are gathered from relevant departments
• Compilation of reports and identification of missed KPIs and potential trends
• Circulation of reports, at review step and finalization step, to the appropriate distribution lists within agreed timelines
• Following up with relevant employees to obtain missing data and responses
• Escalation of any potential issues to Associate Manager, Quality Projects and Metrics.
• Tracking of all actions through to completion
• Maintenance of report templates in the PrimeVigilance Quality Management Control System
• Provision of Quality and Compliance Metrics Data when requested for the purposes of audits and inspections.

SPECIFIED ADDITIONAL RESPONSIBILITIES

When required, the Associate, Quality Projects and Metrics will also:

• Support the Quality Management Team with tasks including, but not limited to:
• Administration, tracking and management of PrimeVigilance Controlled Procedures and related training
• Managing and administrating internal technical and periodic training programmes for PrimeVigilance employees
• Reviewing and approving Access Requests to PrimeVigilance’s controlled systems
• Managing and maintaining the PrimeVigilance Quality Management Control System
• Support the Associate Manager, Quality Projects and Metrics with assigned quality related projects and responsibilities.

Qualifications

• High school or university graduate
• 0-3 years of experience in administrative position
• Good communication skills
• Experience with administrative work
• Advanced literacy (MS Office)

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.