Emmanuel Osong Noumbissie

About Emmanuel Osong Noumbissie

Professional with practical experience overseeing the planning, development and execution of an organization\'s goals and objectives, business functionality, risk management and financial modeling. Public health experience in clinical trials, active surveillance, patient safety, pharmacovigilance (PV) and global health. Epidemiologist with additional experience in supporting clinical research activities such as - clinical trial designs, protocol development and patient safety monitoring activities, to include adverse event reporting and active surveillance of adverse drug reactions for post marketed products, development of policies and guidelines related to pharmacovigilance and regulatory affairs, data analysis and risk-benefit assessment of clinical and non-clinical data. Motivated certified blockchain professional with clinical research knowledge, public health science, marketing, AI and strong organization, leadership, and management skills.

Experience

1. Safety & Pharmacovigilance

   Technical Resources International, Inc.

   Jun 2007 — Present · Bethesda, MD, US

   Manage and Coordinate ongoing protocols. Participate in the business aspect on contracts by producing metrics on a weekly/quarterly basis. • Responsible for implementing and ensuring all contracted deliverables are provided as requested by the client. Including meeting all contracted deadlines. Work with Project staff and client in implementing processes that will allow PVG to successfully meet all the needs of project according to the statement of work. • Reviews Serious Adverse Events (SAEs) and Expedited Adverse Events (EAEs) submitted by clinical research sites. • Writes clinical narratives for the client’s Medical Monitor’s review. • Oversees complex SAE data migration activities from the legacy database to the PVG safety database. • Responsible for the monthly preparation and review of the PVG Monthly Contracts. Responsible for the delivery of the monthly SAE status update to the client’s Medical Monitor. • Proactively collaborate with the information technology department in customizing the safety database to suit client requests for complex and complicated statistical reports on activities related to drug safety. • Consults with the Essential Regulatory Document Control (ERDG) center to identify the sites that have been fully registered for clinical trials. Collaborates with the Safety Oversight Coordination Staff (SOCS) in preparation for Safety Monitoring Committee (SMC) or Data and Safety Monitoring Board (DSMB) meetings. • Oversees confidential communication with pharmaceutical companies in relation to clinical trial agreements. • Multi-task communications between 3rd parties and the PVG group according to the approved clinical trial agreements. • Collaborate with Data Coordinating Centers (DCC) in generating epidemiological statistical data reports. • Oversees the development, preparation, approval, and implementation of project specific procedures (PSPs) and project working instructions (PWIs) related to the contract.

Education

• Harvard Medical School

  Certificate, AI in Health Care: From Strategies to Implementation

• Hood College

  Bachelor of Arts - BA, Biology

• Stanford University

  Artificial Intelligence Graduate Certificate

• Walden University

  Doctor of Philosophy - PhD, Epidemiology