Senior Medical Pharmacoepidemiologist Duties

  • Managed and analyzed national and international (namely, the UK-based General Practice Research Database) health care data concerning epidemiologic aspects of drug safety.
  • Participated in the design and conduct of research projects to collect data related to drug experience and adverse reactions.
  • Participated in the design and development of epidemiological protocols for studies in the areas of major concern to CDER such as trends and/or specific problems that have become evident in the review of adverse reactions data.
  • Maintained continuing liaison with other organizations within the Center and the Agency, the Department, and other agencies.
  • Briefed Division Director and team members on issues related to adverse reactions analysis and interpretation.
  • Participated in meeting with the Division Director and other Center and Agency officials, and the regulated industry on safety aspects related to drugs under evaluation.
  • Lead or served as a member of ad hoc Division task forces and study groups and Agency working groups called to consider problems or direction in the field of pharmacovigilance and pharmacoepidemiology.
  • Reviewed the scientific literature on a variety of products for the analysis of epidemiologic data.
  • Maintained close personal contact with the “state of the art” in science in order to inculcate the most advanced theories and practices in the field of pharmacoepidemiology into the Division and the Office programs.
  • Kept fully abreast of crucial and precedent-setting issues under review within the Division and in the regulated industry as well as related issues in the Office.
  • Participated with a variety of scientists from universities and other government agencies in conferences at which scientific data are discussed and assessed for the purpose of determining scientific validity.