Michelle Arthur Email and Phone Number

• PV case management activities including SAE case narrative review for quality and compliance, including supporting PV/regulatory submissions • Maintain schedule of aggregate reports (e.g., DSURs, 6-Month Line Listings)• Review and update PV documents used by sites across studies (e.g., Safety Management Plans [SMPs], SAE forms)• Review and contribute to DSURs • Contribute to clinical development team meetings, providing up to date and accurate safety information to clinical development• Review and reconcile information regarding contacts for CROs and investigators among all studies to ensure the correct data is maintained • Track compliance metrics for PV vendor activities, measured against pre-agreed timelines and covenants • Comply with Company procedures & SOPs ensuring accurate support updates to procedural documents

• Contribute to individual study Data Management undertakings ensuring model data quality and timely database lock• Effectively manage the efficient, accurate, and timely execution of all Data Management projects throughout the organization• Manage and update DM Safety aspects of Management Plans, Data Review Plans and Data Entry Guidelines on scheduled basis, ensuring total compliance• Communicate with GPV, clinical teams, CRAs and Safety vendors to obtain clinical data for EDC completion and SAE reporting• Review and improve DM reports, listings and other documents generated in the robust Data Management process• SAE, medication error, pregnancy and AESI Reconciliation of all clinical trials • Establish training protocols for Novartis team members on SAE reconciliation and Lab review process• Diligently collected all SAE data needed for medically sound and complete narratives for the safety database

• Lead in reconciliation of all SAE data in Safety database and clinical database for database lock for global clinical trials• Identify Endpoints for all clinical trials and ensure reported appropriately in ECRF and to the Safety vendor• Wrote CSR narratives for endpoints in Phoenix trial• Ensure all SAE data, endpoint, Deaths and Withdrawn data clean and accurate for each clinical trial prior to data lock• Assist Global pharmacovigilance physicians in identifying potential safety trends or signals• Participate in development and review of coding and workflow conventions, SOPs and others • Work closely with pharmacovigilance physicians to handle issues related to adverse events/ SAEs in clinical trials• Contribute to the development clinical trial protocols and other trial documentation such as investigator site study guidance documents, protocol specific abnormal notification ranges, communication pathways, and data management plans• Work with product development teams to obtain appropriate follow-up information and accurate event assessment according to SOPs, work instructions or other protocol specific guidelines• Manage ECRF vendor related issues associated with clinical trial SAE reporting • Create or perform quality checks for line listings and other data generated from the drug safety database and clinical database.

• Lead Safety data manager for all ORION studies assisting in the approval of investigational product (inclisiran) in the EU in 2020 and the FDA later in 2021• Selected to lead integral Project for Eurovision 2 post marketing study• Diligently ensured compliance with all relevant SOPs and GCPs• Conducted and monitored safety review of all clinical labs and associated medication review in ORION project• Provided DM Safety review of Data Management Plan, including Data Review Plan and Data Entry Guidelines• Recommended and implemented techniques to improve Data Management productivity and increase efficiencies across the department• Collaborated with GPV, clinical teams, CRAs and Safety vendors to provide SAE data for the processing of expedited cases

• Assessed individual adverse event reports both foreign and domestic for seriousness, labeling status and relatedness• Prepared adverse event reports in electronic safety database (ARISg)• Assisted in the development of departmental SOPs• Assisted in the collation of serious adverse events for two SBLA submissions to the FDA• Trained staff on database entry and narrative writing for all types of studies• Lead senior drug safety specialist for large clinical trial for cetuximab • Acted as a resource to project team and overall team performance• Lead a team of contract safety professionals in data entry of serious adverse event reports into ARISg.• Assisted in collating the Annual report for cetuximab • Ensured the processing of adverse event reports in a timely manner as specified by the Federal Regulations and departmental Standard Operating Procedures (SOPs)

Generated concise documentation for patient care; organized all admissions and discharges; and ensured accurate medication delivery and recordingLaunched Study of Community Palliative Care patients from data collected on Clinical Reporting SystemPerformed patient assessments; developed, and evaluated care plansFacilitated the delivery of quality patient care in the community and the wardCoordinated services with allied health professionalsResearched and delivered professional development seminars for staffEffectively utilized evidence based nursing practice, quality assurance, and Occupational Health and Safety principles

Provided a high standard of holistic nursing care to critically ill patients in the intensive therapy unitOrganized and delivered artificial ventilation, and airway managementMonitored, recorded, and assessed data obtained from specialized medical equipmentPerformed Cardio Pulmonary Resuscitation; collected, processed and evaluated blood gas samples, and administered all medications