We are PrimeVigilance (part of Ergomed Group), 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.
Job DescriptionThe Quality Specialist is responsible for ensuring that Deviations (Devs) and Corrective and Preventative Actions (CAPAs) are completed in accurate and timely fashion and are managed in compliance with global regulations, legislation and company requirements.
- Lead the administration, tracking and management of Devs and CAPAs
- Support Subject Matter Experts to conduct root cause analysis or Devs and CAPAs
- Lead Devs and CAPAs through the workflow
- Provide support to operations and act as subject matter expert on process of managing Devs and CAPAs
- May participate in audits and inspections to act as a Dev and CAPA subject matter expert
- May support team management, Dev and CAPA team for periodic trending of deviations data across the company
- Preparing metrics on procedures and trainings for internal Quality and Compliance reporting
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 (GVP) experience is desirable
- Previous Clinical (GCP) experience is beneficial
- Prior experience in a Quality and/or Compliance role is required
- 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 (additional language is a plus)
PC Skills:
- MS Office, particularly advanced skills in Excel and Word.
Why PrimeVigilance
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
Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application.
Skills Required
- University degree in Biomedical, Natural, or Health Sciences (e.g., Nursing, Pharmacy, BS/MS)
- Prior experience in a Quality and/or Compliance role
- Experience with deviations and CAPA processes including root cause analysis
- Advanced MS Excel and Microsoft Word skills (MS Office)
- Fluent in English
- Experience using an electronic Quality Management System (eQMS)
- Previous Pharmacovigilance (GVP) experience
- Previous Clinical (GCP) experience
- Prior experience in Medical Information, Medical Devices, or IT
What We Do
Founded in 1997, Ergomed is a global provider of high-quality services to the biopharmaceutical industry, spanning all phases of clinical trials, post-approval pharmacovigilance, and medical information. Ergomed’s fast-growing services business includes an industry-leading suite of specialist pharmacovigilance (PV) solutions, integrated under the PrimeVigilance brand, and Ergomed Clinical Research, a complete, global Phase I-IV clinical development and trial management services with a strong heritage in the development of drugs in rare diseases and oncology. • 1,400+ highly qualified professionals • Global full-service CRO • 25+ years of experience • Therapeutic specialization in oncology • Strong expertise in rare disease trials • Robust clinical safety system • Choice of leading drug safety databases Our key services include: • Clinical Research Services • Pharmacovigilance • Medical Information • Regulatory • Medical Writing • Site Management • Study Physician Support • Biostatistics • Patient Study Support
