PrimeVigilance, an Ergomed brand, was established to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects.

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 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: 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 procedures or training records from the PrimeVigilance Quality Control Management System.

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 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
• 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

• 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.

• Very good English skills (both verbal and written, B2 at least)
• Good knowledge of MS Excel and MS Word
• Administrative experience
• Excellent organisational 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

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

All your information will be kept confidential according to EEO guidelines.

Our Offer:

• Work within a successful, highly – qualified and dynamic team
• Professional training and career development in a fast-growing healthcare company
• Possibility to work from home