Job Description

Company Description

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.



The Quality Management Officer is responsible for ensuring that Quality Events (QEs) and Corrective and Preventative Actions (CAPAs) are completed in accurate and timely fashion and are managed in compliance with global regulations, legislation and PrimeVigilance requirements.

• Lead the administration, tracking and management of QEs and CAPAs at PrimeVigilance
• Support Subject Matter Experts to conduct root cause analysis or QEs and CAPAs
• Lead QEs and CAPAs through the workflow
• Provide support to operations and act as subject matter expert on process of managing QEs and CAPAs
• May participate in audits and inspections to act as a QE and CAPA subject matter expert
• May support the Quality Manager, QE and CAPA team for periodic trending of deviations data across the company
• Preparing metrics on procedures and trainings for internal Quality and Compliance reporting

Qualifications

Education:

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

Experience:

• Previous Pharmacovigilance experience is essential.
• Prior experience in a Quality and/or Compliance role is highly desirable.
• Prior experience in Medical Information, Medical Devices or IT is desirable but not required

Special Skills:

• Experience of using an electronic Quality Management System desirable but not required.

Language Skills:

• Fluent in English

PC Skills:

• MS Office, particularly advanced skills in Excel and Word.

Additional Information

Our Offer

• Competitive salary
• Dynamic team of colleagues in a fast-growing company - possibility for your quick career growth
• Multicultural environment, English as a company language
• Strong emphasis on personal and professional growth
• Extensive and specialized trainings in pharmacovigilance - internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroad
• Friendly working environment with several social events per year

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

Come and join us in this exciting journey to make a positive impact in patient's lives. We look forward to welcoming your application.