QPPV Office Manager
2 semanas atrás
At Elanco (NYSE: ELAN) – it all starts with animals
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the planet and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today
The QPPV Office Manager supports the Global Pharmacovigilance (GPV) organization and the Qualified Person for Pharmacovigilance (QPPV) to maintain and advance the global PV system concerning procedure, training, audit/inspection, PV agreements/contracts, compliance management related tasks, and regulatory requirements ( Pharmacovigilance System Master File (PSMF)) and communication. The QPPV Office Manager coordinates or performs the activities within the department and is in contact with the described interfaces of other departments. By executing the described tasks, the QPPV Office Manager is continuously challenging the existing processes and defined workflows and is seeking creative, new solutions to improve compliance, efficiency and effectiveness.
Tasks:
maintain oversight on procedure and training management within GPV: including support of lifecycle management of GPV-relevant procedures (review, authoring, compilation, finalization) and training implementation;maintain GPV functional training curricula; provide guidance for onboarding/offboarding of GPV colleagues;support nomination process for Local PV Responsibles and maintain oversight;ensure oversight on the Quality Management System (QMS) and local PV procedures;support documentation of training records in/out of the training system;support supervisors in the assignment of training, training curricula and Veeva modulessupport the process of PV Agreements (PVAs) including coordination of generation of new PVAs, incl. selection of templates;support the generation of PVA and related documentation in the systems;maintain the lifecycle of PVAs (global/local) to ensure global oversight for GPV/the QPPV;support the periodic review process in the system;support the monitoring of PV obligations from PVAscoordinate the generation of GPV monthly compliance reports, includingalignment with stakeholders according to procedures, extraction of information from systems;being a contact person/interface to other functions ( Quality);prepare reports on GPV metrics and trendssupport GPV-relevant audits/inspections by ensuring oversight on PV relevant audits/inspections;support of audit planning, , selection of PV partners; preparation of audits/inspections by supporting the data and document selection;
support conduct of GPV audits/inspections;
response generation incl. CAPA management;
CAPA monitoringsupport the generation and management of the Pharmacovigilance System Master File by developing the content and annexes, maintaining documents and annexescoordinate PV communication to external partners/customers according to internal procedures and communication plans
Minimum Qualification (education, experience and/or training, required certifications):
Knowledge of the processes and regulatory requirements in Veterinary Pharmacovigilance is preferredDegree or diploma in veterinary science, pharmacy, life sciences, or related is preferred and/or 2-3 of years experience in regulated industryGood English language skillsAdditional Preferences:
Experience in working effectively in teamsAbility to comprehend interrelations and submit proposals for solutions.Personal accountability and a strong drive for executionAccuracy-
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