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
Requirements
- 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
Ergomed
PrimeVigilance is a specialised mid-size pharmacovigilance service provider established in 2008, offering services in medical information, pharmacovigilance, regulatory affairs, and quality assurance.
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