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Major AccountabilitiesFacilitate trial protocol risk assessment across multiple cross-functional domains (clinical, operational, data management, vendors, regulatory etc.) associated to critical-to-quality (CtQ) data and processes, including definition of quality tolerance limits (QTLs), evaluation of risks based on likelihood, detectability, impact, and ensures mitigation strategy / plans are definedResponsible for drafting, maintaining, and archiving the study specific documentation of risk management activities e.G., Integrated Quality Risk Management Plan (IQRMP)Partners with the RBQM system configuration team to ensure risk indicators, quality tolerance limits and other analytics/visualizations are programmed and functioning per operational requirements in the RBQM systemConduct of periodic central surveillance of the aggregate data at the study and potentially program level, leveraging available analytics/visualizations in the RBQM system, to identify emerging risks and/or issuesFacilitate risk review meetings and discussions with study and potentially program team members to effectively communicate and discuss the findings, support, and encourage robust root cause identification and mitigation strategiesSupports and participates in internal and external audits and inspectionCollaborate with training departments to support training initiatives and aid in the adoption of the RBQM approach.Identifies and shares lessons learned, best practices, successes, case studies, failures,



and process improvement opportunities to promote continuous improvement and consistency with RBQM processesActs as a change agent, champion, subject matter expert and point of contact of RBQM methodology, leading study teams to understand and follow the best practices to achieve maximum benefitExperienceBachelor's Degree in a health-related, life science area, or equivalent combination of education, training, and work experienceMinimum of 4 years of experience in the pharmaceutical or CRO industryPreferred minimum of 1 years of experience in Risk Based Quality ManagementRobust understanding of the drug development process and clinical trial executionKnowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP)Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive ActionsKnowledge of RBQM IT systems or other data analytic systemsDemonstrated ability to analyze data, identify patterns and make recommendations for improvementDemonstrated ability to effectively lead cross functional team meetingsExperience forming cross-functional collaborations; strong interpersonal skillsSupports a culture of continual improvement and innovation; promotes knowledge sharingAbility to influence without authorityThinks creatively; challenges the status quoLanguagesEnglish: fluent written and spoken#J-*****-Ljbffr

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📌 Risk Surveillance Lead (Magdalena)
🏢 Novartis Pharma Schweiz
📍 Magdalena