Company Code Compliance Officer

Gauteng, South Africa

Job Description


Company Description

We 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 organisation 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 Groupxe2x80x99s key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands. We have approximately 9 100 employees at 69 established officesin over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable medicines.

OBJECTIVE:

The role undertakes responsibility to ensure Marketing Code Compliance via the (REP ASSIST) monitoring system for planned events and related promotional and non-promotional / educational materials for Aspen and Third-Party Alliance Partners.

The role supports the SA Commercial Business to realise the commercial strategy and to achieve the annual targeted growth and revenue by giving 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, Aspen Group Code of Marketing Practice, Third-Party Alliance Partner Marketing Codes, and various other acts and guidelines applicable.

The role represents Aspen as CCCO within the Pharmaceutical industry as it relates to the Marketing Code Authority (MCA) and the Aspen Group Code of Marketing Practice.

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 xe2x80x93 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 xe2x80x93 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 xe2x80x93 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
QUALIFICATION AND EXPERIENCE:

Qualifications
  • Matric / Grade 12
  • Bachelor of Pharmacy degree or equivalent
Minimum Requirements
  • Registered with the South African Pharmacy Council as a practicing Pharmacist
  • 5 yearsxe2x80x99 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
Competencies
  • Excellent Communication Skills, including verbal and written proficiency in the English & Afrikaans languages
  • 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
  • Positive, diligent and hard worker
  • 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
Aspen is committed to the principles of equal employment opportunity and suitably qualified job applicants are invited to submit their CV online on or before the 01 March 2024. Preference will be given to applicants from designated groups through a fair recruitment and selection process in accordance with laws governing employment equity, where such laws are applicable to the Aspen.

Internal Applications must be completed using an Aspen mailing address after applicants have informed their direct line managers of their application.

Aspen Pharmacare

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Job Detail

  • Job Id
    JD1297172
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Gauteng, South Africa
  • Education
    Not mentioned