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

Ergomed group is implementing its first group level systems for operations group, in the new eQMS. The Quality System Officer is responsible for providing front line systems support to employees across Ergomed group. The role will also be responsible for managing the eQMS helpdesk, assist with assessing and developing strategies to improve efficiency in company-wide quality systems.

• SME support for company-wide systems users and troubleshoot issues
• Assisting with maintaining, updating, and upgrading of the new eQMS
• Prepare reports for system users that summarize a variety of GxP data
• Manage Quality electronic HelpDesk assisting users in problem-solving
• Assist with presenting and preparing notifications for company-wide systems users
• Support the Quality Systems Manager for various development projects as needed
• Preparing metrics on eQMS data, Power BI, and project management

Qualifications

EDUCATION:

• University degree in Biomedical sciences, Natural sciences or Health Sciences, or Information Technology is required: BS/Master degree in a scientific discipline, or equivalent advanced degree in Information Technology with experience.

EXPERIENCE:

• Previous Pharmacovigilance experience is desirable
• Prior experience in a Quality and/or Compliance role is required
• Prior experience in Quality Management Systems is required
• Experience with API and system connectivity/integration is highly desirable

SPECIAL SKILLS:

• Experience in SharePoint, Electronic HelpDesks, and Customer service is highly desirable.

LANGUAGE SKILLS:

• Fluent in English (additional language is a plus)

PC SKILLS:

• MS Office, particularly advanced skills in Excel, Word, Power BI, MS Planner, and significant electronic systems management
  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

• SME support for company-wide systems users and troubleshoot issues
• Assisting with maintaining, updating, and upgrading of the new eQMS
• Prepare reports for system users that summarize a variety of GxP data
• Manage Quality electronic HelpDesk assisting users in problem-solving
• Assist with presenting and preparing notifications for company-wide systems users
• Support the Quality Systems Manager for various development projects as needed
• Preparing metrics on eQMS data, Power BI, and project managemen