We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We have achieved consistent global growth, with staff across Europe, North America, and Asia, providing services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
PrimeVigilance supports pharmaceutical and biotechnology partners of all sizes, maintaining long-lasting relationships and becoming a global leader in its fields. Our coverage includes all therapy areas, including medical devices.
We invest in our staff through excellent training and development opportunities. We value employee experience, well-being, and mental health, recognizing that a healthy work-life balance is crucial for employee satisfaction and high-quality client service.
Join us on this exciting journey to make a positive impact on patients' lives.
Job Description
Ergomed group is implementing its first group-level systems for operations, including a new eQMS. The Quality System Officer will provide frontline support to employees across Ergomed group, manage the eQMS helpdesk, and assist in assessing and developing strategies to improve the efficiency of company-wide quality systems.
* Subject Matter Expert (SME) support for company-wide system users and troubleshooting issues
* Maintaining, updating, and upgrading the new eQMS
* Preparing reports for system users summarizing GxP data
* Managing the Quality electronic HelpDesk and assisting users with problem-solving
* Presenting and preparing notifications for system users
* Supporting the Quality Systems Manager in various development projects
* Preparing metrics on eQMS data, Power BI, and project management
Qualifications
Education:
* University degree in Biomedical Sciences, Natural Sciences, Health Sciences, or Information Technology is required. An advanced degree or equivalent experience in a scientific discipline or IT is preferred.
Experience:
* Desirable: Previous Pharmacovigilance experience
* Required: Experience in a Quality and/or Compliance role
* Required: Experience with Quality Management Systems
* Highly desirable: Experience with API and system connectivity/integration
Special Skills:
* Experience with SharePoint, Electronic HelpDesks, and customer service is highly desirable.
Language Skills:
* Fluent in English; additional languages are a plus.
PC Skills:
* Proficiency in MS Office, especially advanced Excel, Word, Power BI, MS Planner, and electronic systems management.
Additional Information
We prioritize diversity, equity, and inclusion by fostering an equal opportunities workplace and a human-centric environment where all backgrounds can contribute and grow.
Success requires a human-first approach, as our people are our greatest strength in improving lives.
We offer:
* Internal training and career development opportunities
* Focus on personal and professional growth
* A friendly, supportive environment
* Opportunities to work globally with English as the company language
Our core values—Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging—are central to our operations. If these resonate with you, PrimeVigilance could be a great fit!
We look forward to your application.
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