Tom Ogungbemi

About Tom Ogungbemi

Accomplished, skilled, and highly dedicated Pharmacovigilance Lead credited with vast professional roles including Clinical Study Specialist, Drug Safety Specialist, Drug Safety Consultant, and Physician. Holds a formal education with a Bachelor of Medicine and Bachelor of Surgery and a Master’s in Public Health. Illustrates strengths in detection, assessment, and prevention of adverse effects associated with drugs and medical devices. Reviews safety-related data from clinical trials for content, quality, and adherence to regulatory guidance and protocols. Provides reliable and effective assessment of the risk-benefit profiles of pharmaceutical products along with assisting in quarterly and annual global regulatory safety reports. Offer collaborative communications with all members and levels of the organization.

Experience

1. Senior Director Global Patient Safety

   Eli Lilly and Company

   Oct 2022 — Present · Indianapolis, IN, US

   Provide global medical leadership and input into all aspects of assigned product(s) safety, including surveillance programs and risk management planning. •Ensure proactive safety surveillance: i. lead risk management activities for assigned products globally. ii. lead and guide the surveillance activities of scientists on the team including signal detection and clarification activities and risk evaluation activities; provide support, training, and continuous improvement as appropriate. manage decisions and actions to be taken, including communication to appropriate customers (e.g, Product Teams, Management, Affiliates, and Regulators), and iv. liaise with GPS Medical Area Directors and with Lilly Medical Therapeutic Area Team Leaders and Directors, as appropriate, to fulfill safety obligations. •Build collaborative working relationships with other Global Patient Safety Physicians and development and brand teams medical globally to ensure full cooperation and high-quality medical evaluation of safety data for global regulatory purposes •Provide Global Patient Safety expertise to internal customers (e.g, regulatory, early phase development, business units). •Lead process and provide medical input for review of Suspected Adverse Reactions •Demonstrate knowledge in pharmacovigilance and risk minimization, which includes an understanding •Provide training, coaching, and mentorship to safety surveillance scientists, other GPS Medical physicians, and clinical research scientists with respect to medical aspects of safety surveillance. •Provide input to Global Patient Safety Leadership Team and Safety Review Committee as required; actively contribute to the management of Global Patient Safety at the strategic level. •Represent Global Patient Safety within the company and externally; and Review and comment on external regulatory policy and trends affecting Global Patient Safety.

Education

• Università degli Studi Guglielmo Marconi

  Executive MBA, Business Administration and Management, General

  2022 — 2023

• Obafemi Awolowo University

  Bachelor of Medicine, Bachelor of Surgery - MBChB, Medicine

  1999 — 2007

• Harvard T.H. Chan School of Public Health

  Master of Public Health - MPH, Health Management and Policy

  2011 — 2012