Compliance Officer (Aspen Office In South Africa) at Aspen Pharma Group

OBJECTIVE OF ROLE

• The 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 partner

KEY RESPONSIBILITIES

Support 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 Monitoring

• Support 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

Inspections

• Support 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

Requirements
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