Job description
Company Description
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.
Job Description
The Quality Management Assistant for the Procedures and Training team 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.
ROLE AND RESPONSIBILITIES
- Supporting the 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
- 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:
- 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 procedures or training records from the PrimeVigilance Quality Control Management System.
For the Company:
- Quality oversight
- Audits, inspections and internal Compliance Assessments
- 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, nonconformities and issues - and resulting CAPA plans
- Identify and escalate serious and/or systemic issues to (Associate) Director of Quality Management
- Metrics, analytics and trending
- May supports the Quality Management team in obtaining metrics data for oversight of and reporting on PrimeVigilance’s Quality Management System
- May support the Quality Management team in the trending of metrics data and identifying opportunities for improvement
- May develop, maintain and manage periodic Quality and Compliance reports (including metrics and trending) on behalf of the Quality Management team
- Quality Management Control System (QMCS)
- 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 and in managing relevant project-specific training
- May act as subsystem administrator for the Quality Management Control System
- May participate in efficiency projects to improve the use and management of the Quality Management Control System
- Change management of controlled systems
- On behalf of Quality Management, may approve access to PrimeVigilance Controlled Systems for employees and clients Training
- Supports the Quality Management team in managing and overseeing the programme for PrimeVigilance’s technical and periodic training activities
- May act as a Trainer for QMS-related training activities provided by the Quality Management department
- Other Supportive Responsibilities: · The Quality Management Assistant will support the PrimeVigilance Senior Leadership team and the (Associate) Director of Quality Management as needed
Qualifications
- Medical, science, data analysis, economy student who is interested in quality management and available to work 15 hours per week(part-time remote position), ideally 3 hours per day
- 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
- Fluency in English
- MS Office (Word, PowerPoint, Excel)
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
Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application.
