Compliance Officer

South Africa
Permanent
Full-time

2 days ago

COMPANY DESCRIPTIONWe are a global specialty and branded pharmaceutical company, improving the health of patients across the world through our high quality and affordable medicines. Active at every stage of the value chain, we are uniquely diversi?ed by geography, product and manufacturing capability.Aspen is a dynamic organization built on entrepreneurial strength and forward-thinking minds. We attract high performing individuals who are passionate about their career and have a desire to exceed expectations. At Aspen, not only do we source for the best talent, but we also provide a host of opportunities for continuous development.The Group’s key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands. We have approximately 9 100 employees at 69 established offices in over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable medicines.OBJECTIVE OF ROLEThe role is responsible to support the Company Code Compliance Officer to ensure compliance of Pharmacare Limited and its employees with the rules and regulations of the South African Code of Marketing Practice for Health Products Code and Guideline, the quality requirements of the Medicines and Related Substances Act, 101 of 1965 as amended, the Aspen Group Code of Marketing Practice, Third-Party Alliance Partner Marketing Compliance requirements, and various other acts and guidelines applicable.The role provides operational and administrative support to the CCCO and employees of Pharmacare Limited, in applying and maintaining compliance, including the systems to record, manage and monitor compliance, and to facilitate training on compliance requirements, including the Code and other relevant policies, procedures, regulations and guidelines, in relation to Third party partnerKEY RESPONSIBILITIESSupport in the Management of Code Compliance:

Support CCCO in implementing an effective compliance program to Aspen employees in accordance with the Marketing Code and compliance legislation applicable to the pharmaceutical industry, for Aspen and Third-Party Alliance Partner products
Serve as a trusted partner for the Commercial, Sales and Marketing employees, ensuring the Company culture of compliance is embedded into day-to-day business
Support with compliance monitoring on activities as aligned with CCCO to ensure we do not breach the policies, contracts or legislation
Database maintenance

Assist CCCO with Compliance Activities for Third-Party Alliance Partner

Support in the coordination of regular Third-Party Alliance meetings, record meeting minutes and follow-up on meeting action steps
Assist with various requests from 3rd party on compliance queries and contracts.
Compliance monitoring and reporting
Align with CCCO on potential or identified deviations to ensure risk mitigation and CAPA is raised

Rep Assist system

Review promotional and non-promotional activities on the Repassist system for compliance, including close-out
Liaise and support commercial employees in regard to promotional and non-promotional activities and Repassist requirements
Support CCCO to draw up and maintain guidance documents for the use of and/or training on Rep Assist where required
Support CCCO and IT with System maintenance / updates / changes, in line with Code or when ways of working are updated
Support CCCO with user updates or user support, where needed
Assisting users with advice on the program in line with the code

Database

Support with Teams Channel maintenance
CCCO portal maintenance
MCA: Maintain monthly keep relevant and current
Rep Assist: Maintain monthly
Certificates: Maintain monthly
MCA trackers: Maintain monthly – send out reminders and logon details

Customer Service * Serve as a trusted partner for the Commercial, Sales and Marketing employees, ensuring the Company culture of compliance is embedded into day-to-day business

Assist the Sales, Marketing and Medical teams with uploads, templates, checklists, queries and any other support, as required, in order to ensure compliance with the Code and relevant policies. Procedures and guidelines.
Respond to queries in 24 hours and resolve within 72 hours where possible

Training - support with training of staff on applicable

SOPs
Rep Assist system
Expense process
Marketing Code/s to ensure that everyone follows Ethical and compliant marketing practices.
Ensure and maintain MCA code certification for all Sales and Marketing staff and relevant support staff
Third party partner compliance requirements
Draw up and maintain guidelines for training

MCA

MCA Website Maintenance
Aspen Representative Sales, Marketing and in scope Commercial employees

MCA website maintenance

Loading of profiles
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 and MonitoringSupport CCCO with Reporting and Monitoring on

Periodic reports for Third-Party Alliance Partner as stipulated in the relevant agreement
Monthly report to CCCO, Responsible Pharmacist and AGI
RSM and Manager reports as required
Monthly MCA report for license renewals
Rep Assist database report for integrity and check on profile changes
Quarterly monitoring on all activities for Third Party Partner

InspectionsSupport CCCO and Commercial Team with preparation, analysis and reporting for Third Party Partner inspections

Prepare reports
Evaluate and analyze all promotional and non-promotional activities including supporting data, training records, governance records and other related data
Any other activities required for preparation and participation in inspections

EDUCATIONAL REQUIREMENTS

Matric / Grade 12
Technical qualification related to the pharmaceutical industry is a bonus

KNOWLEDGE & EXPERIENCE REQUIREMENTS

3 to 5 years’ experience in the pharmaceutical industry in a Compliance, Marketing or similar Regulatory Affairs or Medical / Compliance role
Intimate knowledge and experience of the Marketing Code Authority Compliance 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, as amended)
Advanced knowledge of SAHPRA requirements and guidelines
Sound knowledge of the pharmaceutical industry

SOFT SKILLS REQUIREMENTS

Excellent communication skills, including verbal and written proficiency in the English & Afrikaans
Administrative, planning and organizational skills
Electronic database management skills
Report writing skills

High level of integrity, ethical values and confidentiality
Makes good decisions
Customer focus / service orientated, and outcome based
Initiating action, follow up and time management
Ability to prioritise and co-ordinate work
Self-motivated
Quality orientation
Stress tolerance and conflict resolution
Problem solving, attention to detail and analytical skill
Contribute special expertise
Ability to decide, action and assess when to execute
Methodical implementation skills

COMPUTER SKILLS REQUIREDThe applicant must have advanced computer literacy skills on the Microsoft Windows Applications (including Word, PowerPoint, Outlook and Excel).Preference will be given to previously disadvantaged groups. Suitably qualified applicants are invited to submit their CV’s online on or before 9 September 2025. Please note that if you have not heard from the HR department within 30 days of this advert closing, your application has unfortunately been unsuccessful.Internal Applications must be completed using an Aspen mailing address after applicants have had informed their direct line managers of their application for this specific role.

Aspen Pharmacare

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