Ensure quality management of PV deviations (RCA, CAPA, process compliance and timelines).
Identify quality risks and implement appropriate corrective actions.
Contribute to PV quality documentation and the annual quality plan.
Support the Quality Management System (QMS) through monitoring of CAPAs, KPIs, deviations and changes.
Participate in audits/inspections and ensure compliance of partners and suppliers.
Requirements
Education: Master’s degree in Life Sciences with a specialization in Quality Assurance/Pharmacovigilance (QA/PV) or Pharmacist.
Experience: Initial experience in pharmacovigilance (PV) and/or quality assurance (QA) in managing PV deviations — ability to assess the adequacy of root cause analyses (RCA) and proposed CAPA (corrective and preventive action) plans from various stakeholders, and to guide them as needed from a QA/PV perspective.
Skills: Solution-oriented, ability to work in an international environment, strong interpersonal skills. Proactive in anticipating issues, identifying risks and resolving problems.
Languages: Excellent written and verbal communication skills in English.
Tech Stack
Vue.js
Benefits
Why join us? At Excelya, we combine a passion for science and a true team spirit to redefine excellence in healthcare.
What makes us unique: We are a young, ambitious healthcare company of 900 Excelyates, aiming to become the leading mid-size CRO in Europe while providing the best employee experience. Our one-stop provider service model — full service, FSP and consulting — lets you work across varied projects. Alongside recognized experts, you will contribute to the development of scientific, operational and human knowledge to improve the patient journey.
"Excelling with care" means working in an environment that values your natural talents, encourages boldness and supports the development of your potential so you can fully contribute to our collective mission.