•Provided leadership to the audit and compliance organization based in US and Europe •Ensured the coordination and execution of a risk-based audit program and effective CAPA management resulting from audits, health authority inspections, non-compliance and incidence or deviations. •Acted as QA subject matter expert in multiple cross functional work teams including SUSAR reporting to investigators, Signal Detection process and documentation, engaging key stakeholders concerning clinical trials•Writes, reviews, approves standard operating procedures, •Documented Quality events related to QMS and escalated to senior management •Managing issues performing quality investigation, root cause analysis, and Corrective and Preventive actionsTrending and presenting non-compliance and significant events to senior management for potential actions across different organizations or sectorsQualification and Oversight of third-party PV vendorsExpert in pharmacovigilance regulations • EU GVP modules I-VI with a focus on quality systems for pharmacovigilance• US Food Drug and Cosmetic Act Section 505-1 REMS (Risk Evaluation and Mitigation Strategy)• FDA 21 CFR including part 4 21 CFR 4 Combination Products Evaluated end to end implementation of US FDA REMA programs for compliance with US FDCA Section 505-1 and approved REMS program requirements.Assessed risk of the PV system in order to create strategic and tactical plans for audit program concerning internal system audits, licensing partners, and distributorsChaired Monthly QPPV Feedback meeting reviewing compliance issues and providing summary and impact analysis for analysis by senior leaders to determine need for additional regional or global actionKey member of safety reporting group – cross functional multi-disciplinary team that interprets and implements new regulatory requirements which included anticipated events, decreasing SUSAR reporting to sites and investigators, changes due to EU Clinical Trial Regulation Created global PV system audit and marketing partner audit schedule using a risk-based analysis and translated risk into audit strategy and risk based operational audit planning.Responsible for the development and qualification (mentoring) of PV auditors creating individual plans and monitoring progress.
Listed skills include Pharmacovigilance, Fda, Gcp, 21 Cfr Part 11, and 22 others.
