T/PIAC 00001-2022 The requirements for professional skills and competencies of a corporate compliance specialist in the pharmaceutical industry

Scope

Scope: This document specifies the professional and technical skills requirements for compliance officers in the pharmaceutical industry, and serves as the basis for training, assessment, and evaluation of the technical skills of compliance officers in the pharmaceutical industry. This document applies to training, assessment, and evaluation activities for the professional and technical skills of compliance officers in the pharmaceutical industry. Main technical content: - Preface and Introduction - Scope - Normative referenced documents - Terms and definitions - General provisions 4.1 Occupational characteristics 4.2 Occupational levels 4.3 Basic requirements 5. Technical skills requirements for junior compliance officers in the pharmaceutical industry 5.1 Identifying compliance obligations, assessing compliance risks, and assisting in planning compliance goals 5.2 Establishing and implementing compliance management systems 5.3 Establishing and operating compliance management organizational structures 5.4 Establishing and implementing compliance management implementation mechanisms 5.5 Evaluating and improving the effectiveness of compliance management systems 5.6 Building a compliance culture 5.7 Pharmaceutical industry knowledge 6. Technical skills requirements for intermediate compliance officers in the pharmaceutical industry 6.1 Compliance management planning and programs 6.2 Identifying compliance obligations and compliance goals, and assessing and analyzing compliance risks 6.3 Establishing and implementing compliance management systems 6.4 Establishing and operating compliance management organizational structures 6.5 Establishing and implementing compliance management implementation mechanisms 6.6 Evaluating and improving the effectiveness of compliance management systems 6.7 Building a compliance culture 6.8 Pharmaceutical industry knowledge 7. Technical skills requirements for senior compliance officers in the pharmaceutical industry 7.1 Compliance mana

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