Operational Quality Officer

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.    Responsible for the deviations and CAPAs in their department, working with Subject Matter Experts (SMEs) Supports SMEs to conduct root cause analysis or deviations and CAPAs Ensures timely completion of actions Acts as point of contact for delivery of audit and inspection CAPA preparation and delivery of actions within agreed timelines Drives audit and inspection readiness within their department Reviews data to drive continuous improvement and excellence in quality. Delivers proactive department specific audit and inspection readiness training, Works with department SMEs to arrange targeted interview practice Contributes to development of training material for departmental quality Ensures delivery of data required for quality and compliance metrics Works closely with quality counterparts and head of department to drive improvement of departmental quality Education: University degree in Biomedical sciences, or relevant experience. Experience: 2-3 years of work experience in pharmacovigilance with at least 2 years ICSR experience a necessity Prior experience in a Quality and/or Compliance role is required Problem Solving skills, approaching issues independently, and using one’s own initiative is necessary Special Skills: Experience of using an electronic Quality Management System desirable Excellent communication (written and verbal) skills Organization skills, including attention to details and multitasking Delegation skills Planning and time management Technical skills Team working Language Skills: Fluent in verbal and written English  PC Skills: Advanced literacy (MS Office) 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.