The Center for Drug Evaluation and Research, Office of Compliance mission is to shield patients from poor quality, unsafe and ineffective drugs through proactive compliance strategies and risk-based enforcement actions.
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
About U.S. Food & Drug Administration
FDA, Center for Drug Evaluation & Research, Office of Compliance