The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices are safe, and effective.
The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over-the-counter (OTC) and prescription drugs, including biological therapeutics and generic drugs.
The mission of the Office of Compliance (OC) is to shield patients from poor quality, unsafe and ineffective drugs through proactive compliance strategies and risk-based enforcement actions. CDER OC strives to be a model of efficiency, innovation and operational excellence. Guided by law and science, the Office makes strategic and risk-based decisions, communicates clearly with all stakeholders, fosters global collaboration, promotes voluntary compliance and takes decisive action.
The Consumer Safety Officer serves as a scientific advisor for case development, compliance strategies, and regulatory actions, including enforcement, relating to the statutory provisions of compounded drug products, conducts incident management, adverse event report evaluation, and risk mitigation, and performs substantive work with a multiplicity of unprecedented and complex scientific topics, including, but not limited to: human drugs, compounded drugs, unapproved, misbranding and adulteration provision of the FD&C Act, new regulations and scientific policies. As principal advisor, the employee provides expert authoritative advice, guidance and recommendations on drug compliance policies, programs, processes and proceedings.
Reviews recommendations for potential administrative and judicial actions based on unapproved, misbranded and adulteration charges under the Food Drug & Cosmetic Act (FD&C Act) to ensure consistency and adherence to FDA policy; provides enforcement decision and compliance strategies based on review of evidence of violations, compliance policy, public health risks, and availability
Provides scientific and technical input on compliance issues and in regulatory meetings to ensure consistency of interpretation of the compounding provisions of the FD&C Act ; provides technical and scientific expertise on adverse event report evaluation or product quality issues, on risk mitigation strategies, and collaborates with other regulatory partners to develop and execute compliance programs and actions related to compounded drug products.
Assesses, evaluates and prioritizes drug compliance issues, including compounded drugs and marketed product defects. Informs, consults with and advises Center and Office management, Office of Regulatory Affairs (ORA), Agency level managers and other multidisciplinary personnel on difficult and complex regulatory, scientific and drug compliance problems and issues discovered during evaluations. Oversees, monitors, reviews and prepares final reports including Agency determinations and findings. Attends and participates in meetings and conferences with senior level officials from regulated industry to discuss and resolve problems and provides accurate assessment of the state of compliance of a firm or corporation on regulatory compliance and enforcement.
Meets the Office of Personnel Management (OPM) Individual Occupational Requirements (IOR) for Consumer Safety Series, 0696. Please review the entire IOR to confirm the minimum education requirements at the following link: Consumer Safety Series, 0696