Company Code Compliance Officer (Gauteng) at Aspen Pharma Group

MAIN DUTIES:

• Attend to Marketing Code Compliance via the (REP ASSIST) monitoring system for planned events:
• Meetings, sponsorships, promotional items, competitions, grants, DSP, webinars, congresses, stands, digital marketing, influencers, social media campaigns, etc
• Apply all regulations and rules for approval
• Claims process
• Promotional material has been approved on Veeva for the specific event
• Invites; agendas; stand builds; advertising; webinar platforms; slide decks approved and attached
• All costs indicated
• Speaker agreements are in written format and signed before event takes place
• All transfer of Value indicated – travel, accommodation, and any hospitality
• Check for legal notices, use of correct templates
• Disclaimer slides loaded as part of the talk
• Disclosures of affiliation, conflict of interest declared, CDA signed
• All costs have been clearly identified and invoices attached
• No entertainment loaded and shown on programme
• Venue and hospitality are appropriate to the occasion and aligned with all requirements
• Attendance registers signed and uploaded after the event aligned with POPIA
• Is it the right audience for the event – what is the rationale
• Speaker choice indicated with rational for FMV calculation
• Have CPD accreditation been applied for, certificates sent after the event for HCP attendees
• All data and attachments correspond to event loaded on Rep Assist
• All costs tying up with invoices submitted.
• HCP request for CPD and sponsorships included
• Record keeping for minimum 5 years 
• Rep Assist System
• Reporting issues with Rep Assist to IT and developers when needed. 
• Arrange with IT and developers for System updates/changes/maintenance in line with code or when ways of working is updated.
• Loading new sales and marketing employees
• Updating data as and when changes are required
• Assisting users with advice on the program in line with the code 
• Give direction and assistance to the Sales,  Marketing and Medical teams with respect to interpreting, implementing, and applying rules and regulations to meet the quality requirements of the Medicines and Related Substances Act, 101 of 1965 as amended, The South African Code of Marketing Practice for Health Products Code and Guideline, the Aspen Group Code of Marketing Practice, Third-Party Alliance Partner Marketing Code requirements,  and various other acts and guidelines applicable.
• Representing Aspen as CCCO within the Pharmaceutical industry as it relates to the Marketing Code Authority and Group Code.
• Training of staff on applicable SOPs, Rep Assist system, Expense process, Marketing Code/s to ensure we all follow Ethical marketing practices.
• Ensure and maintain MCA code certification for all Sales and Marketing staff
• Compliance contact and responsibility for Third Party Alliance Partners:
• Assist with various requests from 3rd parties on compliance including audits and contracts
• Compliance monitoring and reporting
• Audits
• Marketing Code Compliance – internal (annual) and external (bi-annual)
• Self-inspection audits quarterly, follow up on outstanding documents
• Address issues/findings with greater team
• Trackers kept up to date
• Attendance records kept current
• Alerts for MCA exams and follow up 100% compliant 
• Complaint handling
• Investigation process
• Compilation of letter to Third-Party with Legal assistance
• Obtain Legal and RA reviews of letter
• Company to Company process followed for self-regulation
• Followed through until completion
• Keep record of event on file for auditing and tracking 
• MCA website maintenance
• Loading and updating profiles
• Maintenance of database
• Setting exams for users
• Password reset / logon emails
• Downloading reports and act as required
• Reminders sent to users to renew MCA certifications
• Helping users to navigate the website
• Reporting errors to MCA found on website
• Maintenance of unit licenses to ensure we have enough units to cover examination requirements 
• Reporting
• Quarterly report on Government interaction to Management and Third-Party Alliance Partner
• Quarterly reports for Third-Party Alliance Partners
• Monthly report to Line Manager; Responsible Pharmacist and AGI
• RSM and Manager reports as required
• Monthly MCA report for license renewals
• Monthly Rep Assist database report for integrity and check on profile changes
• Yearly report on Marketing Code declarations 
• VEEVA VAULT - Aspen Promomats
• Checking and approval of promotional and non-promotional material /items applying Code and Regulations for approved usage and distribution

Qualifications

• Matric / Grade 12
• Bachelor of Pharmacy degree or equivalent

Minimum Requirements

• Registered with the South African Pharmacy Council as a practicing Pharmacist
• 5 years’ experience in the Pharmaceutical industry in a Code Compliance or similar Regulatory Affairs or Medical / Compliance role
• Working knowledge of the Marketing Code
• Advanced Knowledge of the legislation applicable to the Pharmaceutical Industry in South Africa (including but not limited to the Medicines and Related Substances Act 101 of 1965)
• Advanced knowledge of SAHPRA requirements and guidelines
• Advanced computer literacy on Microsoft Windows applications (including Word, PowerPoint, Outlook and Excel)

Preferred Requirements

• Intimate Knowledge and Experience in Marketing Code Authority Compliance Code in South Africa
• Technical qualification related to the Pharmaceutical industry is a bonus