Quality Management Assistant (6 months student position)

Company Description

We are PrimeVigilance (part of Ergomed PLC), 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. 

Come and join us in this exciting journey to make a positive impact in patient’s lives. 

Job Description

Role and responsibilities:
The Quality Management Assistant (QEs and CAPAs) will be responsible for all activities involving the tracking and administration of PrimeVigilance Quality Events (QEs) and Corrective and Preventative Actions (CAPAs).
Activities include, but are not limited to:
•Entering accurate QE and CAPA data into the Quality Management Control System (QMCS) in accordance with specified timelines.
•Assigning tasks relating to QEs and CAPAs to the appropriate employees.
•Reviewing completion of tasks associated with QEs and CAPAs and escalating non-compliance.
•Generating and distributing reports from QMCS as required.
•Monitoring e-mails in the deviations mailbox and ensuring that they are actioned as appropriate.
•When required, the Assistant, 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.
•Reviewing and approving Access Requests to PrimeVigilance’s controlled systems.

Qualifications

Requirements: 

• Good communication skills
• Experience with administrative work
• Advanced English (verbal and written)
• Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint

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.