OBJECTIVE OF ROLE

• To support the SA Commercial Business to realise the commercial strategy and to achieve the annual targeted growth and revenue through successful new product introductions and maintenance of current product portfolio in the South Africa and South African Development Community (SADC) region, by ensuring successful Marketing Authorisation and variation approval from the SAHPRA and  Regulatory Authorities of the SADC member states within the committed timeframe. 
• To ensure Aspen Pharmacare’s SA product portfolio complies with the related Acts and guidelines to support and maintain registration in South Africa.  To ensure growth and sustainability of Aspen Pharmacare’s SA product portfolio within the legislative framework of the country and in compliance with the company strategy. 
• The role undertakes responsibility for compliance with the Regulatory Medical Information and Compliance requirements for the New Product Launch Pipeline and the existing  product portfolio in the region, through the successful completion of assigned activities according to the South African and SADC Regulatory plan. 
• To perform Medical Information and Compliance monitoring activities for Aspen in accordance with procedural documents and relevant governing group policies. 
• To meet the needs of healthcare providers and patients/consumers through collaboration with internal customers to ensure delivery of accurate and scientifically balanced medical information, and promotional and non-promotional material, and to respond to unsolicited inquiries from regulatory authorities,  including clients and managed healthcare organisations in a manner that will help them make a decision regarding therapy for a patient or product selection. 

KEY RESPONSIBILITIES:

FINANCIAL

• Effective utilisation of resources to keep processes cost effective.
• Adhering to Regulatory Affairs budget and forecasts. 

MEDICAL INFORMATION (MI)

• Providing support within the MI function in responding to labelled and off-label medical information enquiries for Aspen and contractual partners.
• Providing compliant responses to internal and external customers.
• Creating and maintaining standard responses (SRs) and Objection Handlers (OHs).
• Ensuring that the relevant department/s are informed in a timely manner (at receipt or at least within 24 hours) following the receipt of adverse events or product quality complaints/potential counterfeit medicines.   This include performing a daily check on the dedicated medical information inbox and MAfax inbox.
• Ensuring that Affiliate/Distributor/MI is adhering to Aspen’s Policy in providing scientific support to internal and external customers.
• Identifying gaps and suggesting ways of process improvement in MI.
• Ensuring that the reconciliation between the Medical Information function and Pharmacovigilance and the Quality department is effective by performing ad hoc reviews on reconciliation files.
• Ensuring that any suggested improvements within the professional information and/or patient information leaflets are communicated to the PV Lead at the point of identification.
• Supporting the line manager in generation of medical information reports showing trends in medical information enquiries received.
• Managing after hour MI enquiries on a rotational basis.
• Ensuring telephony system testing documents are completed as per allocation.
• Ensuring compliance to Key Performance Indicators (KPIs) response timelines. 
• Ensuring a professional attitude is displayed when responding to a customer’s needs.

PROMOTIONAL MATERIAL, SCIENTIFIC MATERIAL REVIEW AND COMPLIANCE MONITORING

• Reviewing and approving promotional material relating to the advertising and promotion of medicines and related products for the SA and SADC markets in compliance with applicable legislation, codes of practice and any other applicable regulations/guidelines and corporate requirements.
• Reviewing and approving educational, scientific and other non-promotional material for the SA and SADC markets in compliance with applicable legislation, codes of practice and any other applicable regulations/guidelines and corporate requirements.
• Liaising with marketing divisions regarding advice, queries, and timelines in relation to the above.
• Assisting with the review of information relevant to each product.
• Attending promotional campaign concept presentations at the request of the marketing teams to provide regulatory support and input.
• Ensuring that compliance monitoring is performed on all territories and non-compliances are escalated in a timely manner to the line manager as per Aspen group policies.
• Supporting the line manager in developing and maintaining procedural documents for compliance monitoring.
• Supporting the training department in providing recommendations for improvement and compliance with Aspen group policies following compliance monitoring review.
• Supporting the line manager in generating reports associated with compliance monitoring activities.

REGULATORY AUTHORITY SUBMISSIONS (INCLUDING SECTION 21/36):

• Performing clinical due diligence for new intellectual property as received from the regulatory function.
• Creating Professional Information (PI) and Patient Information Leaflets (PILs) for new IP.
• Creating company core data sheets.
• On time responses to clinical evaluation recommendations (CERs) and clinical screening enquiries.
• Accurate compilation and filing of the electronic submission documentation.
• Accurate completion of all tasks pertaining to submissions as specified in the relevant procedural documents.
• Maintaining tracking tools to ensure on time submission and reporting.
• Identifying process enhancements.
• Ensuring accurate uploading of the current approved PIs and PILs to the SA Regulatory Portal and submission to SAHPRA for uploading to the PI/PIL Repository (and relevant platforms).
• Managing Section 21 and 36 submissions.

IMPLEMENTATION OF RISK MANAGEMENT PLAN (RMP) MATERIAL:

• Ensuring that RMP material is created, maintained and rolled out to market.
• Ensuring that the relevant sales force team is adequately trained, and training records are filed.
• Ensuring that tracking tools are in place to ensure logging of material distribution and reporting to SAHPRA.

PRINTED PACKAGING/ARTWORK

• Reviewing and approving concept of new or updated artwork/printed packaging material for medicines and related products for the SA and SADC markets in compliance with applicable legislation and corporate requirements.

AFRIKAANS TRANSLATION OF PROFESSIONAL INFORMATION (PI) AND PATIENT INFORMATION LEAFLETS (PILs) 

• Assisting with the translation and/or validation of Afrikaans PIs (where required) and PILs for both new and existing products.
• Ensuring that translations are undertaken accurately and timeously. 

PROJECT MANAGEMENT 

• Providing assistance with any specific projects and operational support for the MI and Compliance team

MAINTENANCE OF THE ASPEN MEDICALLY CRITICAL LIST 

• Initiating and finalising a bi-annual review of the Aspen medically critical list.

QUALITY MANAGEMENT SYSTEMS 

• Maintaining procedural documents for the Medical Information and Compliance function as specified in the individual KPAs (as per identified     subject matter expert/s).
• Ensuring accurate and ‘real-time’ filing of training records.
• Ensuring ‘real-time’ maintenance of TrackWise/QAlign records.
• Ensuring that relevant documentation requested by auditors is provided in a timely manner during internal and external audits.
• Ensuring that training records are up to date to ensure audit readiness.
• Ensuring that the commercial team members are trained on those RA:SQC procedures where there are shared responsibilities. 

GENERAL 

• Ensuring systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs.
• Adherence to agreed Key Performance Indicators (KPIs).
• Supporting the continuous development and improvement of the Medical Information and Compliance function while upholding Aspen core values.
• Ensuring relevant records are maintained as soft copies and hard copies, as per Pharmacare filing structure/instructions.
• Adherence to Company Health & Safety procedures.
• Participation in training programmes.
• To provide a leadership role as required by taking responsibility for specified areas and coaching of staff.
• Any other duties as assigned by Manager.

Requirements
EDUCATIONAL REQUIREMENTS

• Bachelor of Pharmacy Degree and registration with the South African Pharmacy Council

KNOWLEDGE AND EXPERIENCE REQUIREMENTS

• Minimum 1 to 2 years’ pharmaceutical experience
• Experience in Medical Information is an advantage
• Ability to work with multi geographical locations & time zones
• Experience in medicine legislation and related guidelines and codes of practice preferable
• Regulatory Authority requirements/legislation
• Understanding of the laws and requirements governing the marketing of medicines and printed packaging Guidelines and codes of practice
• Understanding requirements of medical information and information management
• Terminology – understanding the jargon
• Understanding business processes
• Product knowledge
• Industry knowledge
• Dossiers and requirements
• Multilingualism (including Afrikaans) would be an advantage

SOFT SKILLS REQUIREMENTS

• Integrity, good work ethic and ability to meet deadlines
• Self-starter
• Analytical and planning skills
• Accuracy and attention to detail
• Effective organisational skills and ability to prioritise
• Ability to work under pressure and to tight deadlines
• Ability to work in a fast-paced international environment
• Ability to manage projects in a matrices team environment and  with both internal and external partners
• Willing to travel if required
• Presentation skills
• Time management skills
• Service orientation
• Decision making skills
• Customer focused
• Self-confidence
• Organisational awareness
• Information seeking
• Excellent interpersonal and communications skills
• A solutions provider
• Manage evolving deadlines effectively with regular feedback  and updates
• Enthusiasm and drive to take ownership and drive process  initiatives
• Logical thinking
• Positive ‘can – do attitude’
• Work autonomously and have good problem-solving skills
• Honest and trustworthy
• Respectful and highly personable
• Possess cultural awareness and sensitivity
• Flexibility and confidentiality
• Empathy, patience, influence
• Sense of urgency
• Positive and pro-active approach to business tasks
• Business process analysis
• Report writing
• Information gathering and monitoring
• Projects (advantage) 

COMPUTER SKILLS REQUIRED

• Effective use of appropriate IT systems and programs