PV Quality & Compliance Specialist

Tepsivo is a young company on an ambitious mission to reshape the world of Pharma and pharmacovigilance into a modern-day industry. Since our conception in 2020, we’ve become the world’s first fully digital global drug safety provider, with a genuine end-to-end PV system run by our in-house-developed tools. We’re looking for PV Quality & Compliance Specialists who are ready to take on the challenge of helping us remain in compliance while ensuring that the operations run efficiently without excess bureaucracy. While doing this, you get the chance to make a dent in the PV services industry that has so far been dominated by dinosaurs relying on obsolete business models with low value-added activities and manual labor-intensive processes. It’s high time for a change, and that’s what we’re here to do. Are you? What is your ideal background? 2-3 years of experience in pharmacovigilance compliance, quality assurance, or quality management. Preferably, you should also have a good level of knowledge of the GVP requirements and some experience in pharmacovigilance audits and/or inspections. Experience in creating, maintaining, and improving ISO9001, ISO27001, or ISO13485-based quality management systems is a plus. What do we expect you to do? As the PV Quality & Compliance Specialist, we expect you to have excellent attention to detail, a systematic approach to working, be able to balance priorities according to due dates, and have a problem-solving attitude. We expect you to be efficient and take initiative to increase the efficiency of managing quality issues. We expect you to have the ability to work independently and collaboratively and assume complete accountability for all your activities. You should adapt quickly to new tools and operating environments and be comfortable using new software. Last but not least, we expect you to be able to operate in a highly regulated environment requiring full documentation of all performed activities. As the PV Quality & Compliance Specialist, you will report directly to the Director of Quality Management. General areas of responsibility: Audit/inspection managementScheduling and keeping the audit schedule up-to-date with possible changesManage preparation for audits and inspections, responding to pre-audit document requests, and quality management-related questions during audits and inspectionsManaging ad-hoc document requests and maintaining records for auditsRecording audit findings, assigning them to SMEs, and monitoring the closure of findings and responding to audit reports Training managementCreating and maintaining training requirements in the Tepsivo learning management system (LMS)Monitoring training compliance and reporting to the Line Managers and the senior leadership team about issuesIssuing training reports for auditors, inspectors, and management review Document controlAssist in maintaining an up-to-date list of controlled documentsEnsuring documents are periodically reviewed on time, tracking periodic review due dates, and recording periodic document review activitiesPublishing of controlled documents, storage of documents in an electronic document management system (eDMS), and LMSMaintaining information about the effectiveness of approved documents. Corrective and preventive action (CAPA) managementMonitoring creation, assessment, and completion of actions related to closing CAPAsEnsuring the CAPA description and related Findings matchSystematic review and maintaining CAPA status The quality team is involved in almost all aspects of the business and interacts with all teams and most of the customers. This means there are aspects of the role that are not listed above, and we can guarantee a fast-paced environment where no two days look alike. Our modus operandi We’re a modern company and believe in a decentralized approach to management. This means we are strong supporters of providing enough freedom in where you work as well as how. Your boss will not look over your shoulder every day. Instead, you will have transparent access to key company data and objectives, and we will expect you to make informed decisions in the areas of your responsibility. In return, we expect you to be fully accountable for your own work, good or bad. This can only work with people of the right talent and those who genuinely share our values and philosophy. Tepsivo solutions have removed, automated, or otherwise digitized routine PV activities and what is left is value-added work requiring a strong skill set. If you’re selected to work at Tepsivo, that means you’re already among the best of your peers, and that is something we hope to foster and reward accordingly. If you’re ready for a true challenge, then let’s talk! Please submit your CV and cover letter in a single PDF document so we understand what motivates you about this opportunity.