Code Compliance Evaluator

Job Purpose

• To review and approve promotional materials, and promotional activities and ensure that these are compliant with all the statutory laws, regulations, and guidelines as well as with the internal standards set by the company.
• To participate in cross-functional meetings and interactions and to provide regulatory compliance support to cross-functional departments related to the relevant processes.
• To perform pharmacovigilance activities

Key Job Outputs

• Evaluate all promotional material / event/ meeting/ interaction proposals and any other material relevant to Code Compliance to ensure compliance with Act 101 of 1965 as amended, Act 53 of 1974, Act 54 of 1972, SA Code for the Marketing of Medicines, Consumer Protection Act and any other applicable approved dossier and internal company policies
• Maintain Compliance databases
• Provide training to relevant company staff to ensure compliance of all employees with the applicable laws and codes of the industry as well as competence and compliance with internal policies and SOP's
• Drive and enforce compliance with relevant Compliance processes within the company.
• Ensure that the agreed timelines and key performance indicators for these processes are continuously being met
• Participate in cross-functional team meetings to discuss and resolve issues surrounding controversial material
• Ability to interpret and understand changes to the regulations and guidelines and to guide or facilitate implementation on an operational level.
• Author, update and maintain SOPs for the Compliance department, and ensure effective implementation of SOPs.
• Effective document management and filing paper based as well as electronically
• Participate in internal self-inspections and external audits as appropriate
• Compile statistics, monthly and quarterly reports for business updates

Core Competencies

• Attention to detail with the ability to visualize the broader picture
• Ability to read, write and understand English and one other South African language verbal comprehension
• People management skills and negotiation skills
• Networking skills
• Verbal and written communication skills
• Decisiveness and Action-orientated
• Planning & organising
• Ethical responsibility
• Computer Literate in MS Office Word, Excel, Powerpoint, Teams and Adobe Acrobat Pro.
• Self-driven
• Effective at Time Management
• Work independently and as well as within a team

Requirements

• B. Sc Hons or Masters
• Highly proficient in English and one other official language to meet current SAHPRA labelling requirements.
• Ability to assess and interpret regulations and guidelines and ensure practical application of the requirements
• Practical experience in the pharmaceutical sector is not mandatory but would be advantageous.
• Experience in a compliance related role with responsibility for review and approval of promotional material and product labelling is not mandatory but would be advantageous.
• Experience in a Regulatory Affairs / Quality Assurance/ Pharmacovigilance environment or experience in promotional material management in the pharmaceutical industry would be an advantage.
• Sound knowledge of Medicines & Related Substances Control Act Act 101/1965 amended, Pharmacy Act Act 53 of 1974, Foodstuffs, Cosmetics and Disinfectants Act Act 54 of 1972, South African Code of Marketing Practice, Consumer Protection Act of 2010, POPIA and other relevant regulations.