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Pharmacovigilance, Quality Assurance Officer
ExcelyaQuality Manager in pharmacovigilance at Excelya ensuring compliance and process improvement through collaboration with stakeholders. Contributing to documentation and supporting audits while managing quality deviations.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Assurance for Pharmacovigilance, focusing on managing deviations, conducting root cause analyses, and implementing corrective actions. Proficient in supporting Quality Management Systems and ensuring compliance through effective communication and collaboration.
Highest-signal resume keywords
Quality Assurance for PharmacovigilanceRoot Cause Analysis (RCA)Corrective and Preventive Actions (CAPA)Pharmacovigilance (PV)Quality Management System (QMS)
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality ManagementDeviation ManagementRisk IdentificationKPI MonitoringCompliance Audits
Soft Skills
Solution-Oriented MindsetStrong Interpersonal SkillsProactive Problem SolvingAbility to Work in International EnvironmentExcellent Communication Skills
Industry Keywords
PharmacovigilanceQuality AssuranceCAPARCAQuality Documentation
Tech Stack
Tools & technologiesVue.js
About the role
Key responsibilities & impact- 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) by monitoring CAPAs, KPI, deviations and changes.
- Participate in audits/inspections and ensure compliance of partners and vendors.
Requirements
What you’ll need- Education: Master’s degree in Life Sciences with a specialization in Quality Assurance for Pharmacovigilance (QA-PV) or a Pharmacist degree.
- Experience: Initial experience in pharmacovigilance (PV) and quality assurance (QA) handling PV deviations — ability to assess the adequacy of root cause analyses (RCA) and CAPA plans proposed by stakeholders and to provide QA-PV guidance when needed.
- Skills: Solution-oriented mindset, ability to work in an international environment, strong interpersonal skills. Proactive approach to anticipate issues, identify risks and resolve problems.
- Languages: Excellent written and oral communication skills in English.
Benefits
Comp & perks- At Excelya, we combine a passion for science with a genuine team spirit to redefine excellence in healthcare.
- We are a young, ambitious healthcare company with 900 Excelyates, aiming to become the leading mid‑size CRO in Europe while offering the best employee experience.
- Our one-stop provider service model — full service, FSP and consulting — allows you to work on a variety of projects.
- Working alongside recognized experts, you will contribute to the development of scientific, operational and human knowledge to improve the patient journey.
- "Excel 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.