OBJECTIVES 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 Southern 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 through collaboration with internal customers to ensure delivery of accurate and scientifically balanced medical information 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

MEDICAL INFORMATION (MI) 

• Managing the dedicated medical information inbox and MAfax inbox.
• Performing a daily check on the dedicated medical information inbox and MAfax inbox to ensure that all adverse events (AEs), product quality complaints (PQCs) and potential counterfeit medicines are reported to the relevant department function within 24 hours of receipt.
• Responding to labelled medical information enquiries received for internal or external sources.
• Responding to off-label medical information enquiries received from external sources from approved standard responses (SRs) and oversight from medical information and compliance pharmacist.
• Monthly reporting of agreed MI compliance requirements and metrics.
• Maintaining the MI logging system.
• Ensuring adequate connection, coverage and performance of routine testing of the MI/PV telephony system as per Aspen procedures.
• Managing the MI hardcopy source documentation (as relevant).
• Providing PV/QA support to data management in reconciliation of AEs and PQCs. This includes follow-up of any enquiries/issues raised as a result of a PV/QA reconciliation.
• Ensuring that reconciliations as specified in the Safety Data Exchange Agreements (SDEAs) are performed timely and documented as per Aspen Pharmacare procedures.
• Ensuring compliance to Key Performance Indicators response timelines.
• Ensuring that a professional attitude is displayed when responding to a customer’s needs.
• Ensuring that internal and external customers are updated, under supervision, as to the progress of their enquiries.
• Liaising with internal customers e.g. commercial, manufacturing sites, quality related departments, public health, exports, Aspen Communication Centre to ensure information is obtained to respond to MI requests.
• Managing and tracking product specific programmes e.g. Section 21 patient access. 

REGULATORY AUTHORITY SUBMISSIONS (INCLUDING SECTION 21/36)

• Ensuring a comprehensive understanding of the competent health authority’s requirements, Regulations and Guidelines.
• Supporting the creation of Professional Information (PI) and Patient Information Leaflets (PILs) for new IP.
• Supporting the creation of company core data sheets.
• Supporting the on-time responses to clinical evaluation recommendations.
• Accurate compilation and filing of the electronic submission documentation.
• Accurate completion of all tasks pertaining to submissions as specified in the relevant procedural documents.
• Identifying process enhancements. 

IMPLEMENTATION OF RISK MANAGEMENT PLAN (RMP) MATERIAL

• Supporting the creation, maintenance and roll-out of RMP material to market.
• Supporting the training of the relevant sales force team and filing of training records.
• Supporting the implementation of tracking tools and reporting to SAHPRA. 

MAINTENANCE OF THE ASPEN PORTAL AND SAHPRA PI/PIL REPOSITORY  

• Ensuring that the current PIs and PILs for Aspen and contractual partners’ products are accessible on the SA Regulatory Portal.
• Ensuring that the current PIs/PILs for Aspen are provided to SAHPRA for uploading to the SAHPRA PI/PIL Repository (or other relevant platform/s).
• Ensuring that Dear Healthcare Professional Letters (DHPLs), recall letters, updated medical critical lists and training material are uploaded to the SA Regulatory Portal on receipt.
• Ensuring that notifications are sent to the relevant internal business contacts when new/updated documents are uploaded to the Aspen Portal for regulatory documents.
• Performing an annual check/clean-up of the SA Regulatory Portal to ensure the correctness of the files present in the SA Regulatory Portal and SAHPRA PI/PIL Repository (or other relevant platform/s).
• Maintaining tracking tools to ensure on time reporting. 

PROJECT MANAGEMENT

• Providing assistance with any specific projects and operational support for the Medical Information and Compliance team.

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).
• 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.
• Archiving and storage of documents as specified in the relevant company procedural documents.
• Ensuring that the annual Business Continuity Plan (BCP) checks are performed for sign off by the Medical Information and Compliance Lead.
• Ensuring that the commercial team members are trained on those RA:SQC procedures where there are shared responsibilities. 

FINANCIAL

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

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).
• Support 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.
• Any other duties as assigned by Manager. 

Requirements
EDUCATIONAL REQUIREMENTS

• Qualified Post Basic Pharmacist Assistant or Post Graduate degree in science

KNOWLEDGE & EXPERIENCE REQUIREMENTS

• 5 years plus in a retail/hospital/pharmaceutical/healthcare environment
• Working with and according to contracts and/or tenders.
• Regulatory Authority requirements/legislation
• Understanding requirements of medical information and information management
• Terminology – understanding the jargon
• Understanding business processes
• Product knowledge
• Industry knowledge
• Dossiers and requirements 

SOFT SKILLS REQUIREMENTS

• Business process analysis
• Report writing
• Information gathering and monitoring
• Projects (advantage)
• Positive ‘can – do attitude’
• Work autonomously and have good problem-solving skills
• Able to cope with evolving deadlines effectively with regular feedback and updates
• Honest and trustworthy
• Respectful and highly personable
• Possess cultural awareness and sensitivity
• Flexibility and confidentiality
• Positive and pro-active approach to business tasks
• Enthusiasm and drive to take ownership and drive process initiatives
• Integrity, good work ethic and ability to meet deadlines 

COMPUTER SKILLS REQUIRED

• Advanced computer experience (Application Software Packages, Data Capturing, MS Office (all programs)