Quality Specialist, Deviations & CAPAs (PV - Quality Management)

Company Description

Medicine moves forward here. So will you. 

At PrimeVigilance, patient safety is not one part of the job. It is why we exist. 

We are a global pharmacovigilance specialist. Our teams help clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post-marketing surveillance. Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that matters early and turning it into insight our clients can act on. 

That work takes curious minds, problem-solvers and experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America, Asia and Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from. 

If you want a role with real purpose, global reach and the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you. 

Job Description

The 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

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 (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.

Additional Information

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.  

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here. 

• Quality: we hold ourselves to the standard patients deserve. 
• Integrity and trust: we do the right thing, especially when it is hard. 
• Drive and passion: we care about the outcome, because someone is waiting on it. 
• Agility and responsiveness: we move quickly, because patients cannot wait. 
• Belonging: everyone is welcome, and every voice counts. 
• Collaborative partnerships: we go further by going together. 

We look forward to welcoming your application.