Quality System Officer

Prime Vigilance Ltd; Guildford; On-site; GBP 35,000 - 55,000; Full time

Job summary

An established industry player in pharmacovigilance is seeking a Quality System Officer to provide vital support across its operations. This role involves managing the eQMS helpdesk, assisting with system updates, and preparing insightful reports on quality data. Join a company that values employee well-being and offers a friendly, supportive environment. With a strong emphasis on personal and professional growth, this is an exciting opportunity to make a positive impact in the lives of patients globally. If you are passionate about quality management and thrive in a diverse workplace, this could be the perfect fit for you.

Benefits

Training and career development opportunities

Strong emphasis on personal and professional growth

Friendly, supportive working environment

Opportunity to work with colleagues globally

Qualifications

• Experience in Quality and Compliance roles is required.
• Previous experience in Pharmacovigilance is desirable.
• Strong PC skills, particularly in Excel and Power BI.

Responsibilities

• Provide front line systems support to employees across Ergomed group.
• Manage the eQMS helpdesk and assist users in problem-solving.
• Prepare reports summarizing GxP data for system users.

Skills

Pharmacovigilance

Quality Management Systems

API and system connectivity

Customer service

Fluent in English

Education

University degree in Biomedical sciences

Master degree in a scientific discipline

Advanced degree in Information Technology

Tools

SharePoint

MS Office

Power BI

MS Planner

Electronic HelpDesks

Job 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 withmaintaining, updating, and upgradingof 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 Technologyis required: BS/Master degree in a scientific discipline, or equivalent advanced degree in Information Technologywith 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 languageis 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

We look forward to welcoming your application.