Medical Reviewer Duties

  • Acted as a member of a multidisciplinary team which had the overall responsibility for pre- and post-marketing safety evaluation of neurology and psychiatry drugs in the Division.
  • Reviewed NDA safety data with regard to deaths, discontinuations, common and/or serious adverse events, laboratory analyses findings and ECG findings. Initiated additional analyses as deemed necessary. Made a recommendation as to whether a development program should be halted or as to how a safety issue should be monitored in further trials.
  • Reviewed and modified sponsors’ proposals for the safety sections of the product labelling, as deemed necessary by my review of the pertinent NDA.
  • Reviewed and evaluated risk management plans
  • Reviewed, evaluated, and redesigned as necessary protocols for epidemiological studies that are proposed by sponsors to investigate safety issues that arise during development or in post-marketing period.
  • Designed, analyzed, and reported studies of adverse event data from clinical development data spanning several drug development programs.
  • Developed requests for and reviewed consults prepared by the Office of Surveillance and Epidemiology (OSE) concerning safety issues with Division drugs.
  • Reviewed, evaluated, interpreted, and abstracted pertinent adverse events experience data from case report forms and from files in the Adverse Event Reporting System (AERS) database. This evaluation required the utilization of medical judgment and epidemiological knowledge in determining the adequacy of clinical documentation, the severity of the adverse reaction, and the possible causal relationship between specific therapeutic agents and the reported adverse reactions.
  • Served as technical/scientific advisor on adverse reactions associated with drugs to other members of the Division and other Divisions.
  • Provided consultation to other clinical reviewers within the Division with regard to interpretation of epidemiological data or methodology.
  • Participated in the revision of drug package inserts, writing of Dear Doctor letters, presentation of adverse event data at scientific meetings, and publication of research in peer-reviewed medical and scientific journals.
  • Kept abreast of new medical developments pertinent to the Division’s drugs in order to anticipate possible safety and reporting issues.
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