OBJECTIVE OF ROLE<\/p>\n
\tTo 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 \u00a0Regulatory Authorities of the SADC member states within the committed timeframe.
\n\tTo ensure Aspen Pharmacare\u2019s SA product portfolio complies with the related Acts and guidelines to support and maintain registration in South Africa. \u00a0To ensure growth and sustainability of Aspen Pharmacare\u2019s SA product portfolio within the legislative framework of the country and in compliance with the company strategy.
\n\tThe role undertakes responsibility for compliance with the Regulatory Medical Information and Compliance requirements for the New Product Launch Pipeline and the existing \u00a0product portfolio in the region, through the successful completion of assigned activities according to the South African and SADC Regulatory plan.
\n\tTo perform Medical Information and Compliance monitoring activities for Aspen in accordance with procedural documents and relevant governing group policies.
\n\tTo 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, \u00a0including clients and managed healthcare organisations in a manner that will help them make a decision regarding therapy for a patient or product selection.<\/p>\n
KEY RESPONSIBILITIES
\nFINANCIAL\u00a0<\/p>\n
\tEffective utilisation of resources to keep processes cost effective.
\n\tAdhering to Regulatory Affairs budget and forecasts.<\/p>\n
MEDICAL INFORMATION (MI)<\/p>\n
\tProviding support within the MI function in responding to labelled and off-label medical information enquiries for Aspen and contractual partners.
\n\tProviding compliant responses to internal and external customers.
\n\tCreating and maintaining standard responses (SRs) and Objection Handlers (OHs).
\n\tEnsuring 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. \u00a0 This include performing a daily check on the dedicated medical information inbox and MAfax inbox.
\n\tEnsuring that Affiliate\/Distributor\/MI is adhering to Aspen\u2019s Policy in providing scientific support to internal and external customers.
\n\tIdentifying gaps and suggesting ways of process improvement in MI.
\n\tEnsuring that the reconciliation between the Medical Information function and Pharmacovigilance and the Quality department is effective by performing ad hoc reviews on reconciliation files.
\n\tEnsuring that any suggested improvements within the professional information and\/or patient information leaflets are communicated to the PV Lead at the point of identification.
\n\tSupporting the line manager in generation of medical information reports showing trends in medical information enquiries received.
\n\tManaging after hour MI enquiries on a rotational basis.
\n\tEnsuring telephony system testing documents are completed as per allocation.
\n\tEnsuring compliance to Key Performance Indicators (KPIs) response timelines. \u00a0
\n\tEnsuring a professional attitude is displayed when responding to a customer\u2019s needs.<\/p>\n
PROMOTIONAL MATERIAL, SCIENTIFIC MATERIAL REVIEW AND COMPLIANCE MONITORING<\/p>\n
\tReviewing 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.
\n\tReviewing 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.
\n\tLiaising with marketing divisions regarding advice, queries, and timelines in relation to the above.\u00a0
\n\tAssisting with the review of information relevant to each product.\u00a0
\n\tAttending promotional campaign concept presentations at the request of the marketing teams to provide regulatory support and input.
\n\tEnsuring 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.
\n\tSupporting the line manager in developing and maintaining procedural documents for compliance monitoring.
\n\tSupporting the training department in providing recommendations for improvement and compliance with Aspen group policies following compliance monitoring review.
\n\tSupporting the line manager in generating reports associated with compliance monitoring activities.<\/p>\n
REGULATORY AUTHORITY SUBMISSIONS (INCLUDING SECTION 21\/36):<\/p>\n
\tPerforming clinical due diligence for new intellectual property as received from the regulatory function.
\n\tCreating Professional Information (PI) and Patient Information Leaflets (PILs) for new IP.
\n\tCreating company core data sheets.
\n\tOn time responses to clinical evaluation recommendations (CERs) and clinical screening enquiries.
\n\tAccurate compilation and filing of the electronic submission documentation.
\n\tAccurate completion of all tasks pertaining to submissions as specified in the relevant procedural documents.
\n\tMaintaining tracking tools to ensure on time submission and reporting.
\n\tIdentifying process enhancements.
\n\tEnsuring 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).
\n\tManaging Section 21 and 36 submissions.<\/p>\n
IMPLEMENTATION OF RISK MANAGEMENT PLAN (RMP) MATERIAL:<\/p>\n
\tEnsuring that RMP material is created, maintained and rolled out to market.
\n\tEnsuring that the relevant sales force team is adequately trained, and training records are filed.
\n\tEnsuring that tracking tools are in place to ensure logging of material distribution and reporting to SAHPRA.\u00a0<\/p>\n
PRINTED PACKAGING\/ARTWORK\u00a0<\/p>\n
\tReviewing 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.\u00a0<\/p>\n
AFRIKAANS TRANSLATION OF PROFESSIONAL INFORMATION (PI) AND PATIENT INFORMATION LEAFLETS (PILs)\u00a0<\/p>\n
\tAssisting with the translation and\/or validation of Afrikaans PIs (where required) and PILs for both new and existing products.
\n\tEnsuring that translations are undertaken accurately and timeously.<\/p>\n
PROJECT MANAGEMENT\u00a0<\/p>\n
\tProviding assistance with any specific projects and operational support for the MI and Compliance team<\/p>\n
MAINTENANCE OF THE ASPEN MEDICALLY CRITICAL LIST<\/p>\n
\tInitiating and finalising a bi-annual review of the Aspen medically critical list.<\/p>\n
QUALITY MANAGEMENT SYSTEMS<\/p>\n
\tMaintaining procedural documents for the Medical Information and Compliance function as specified in the individual KPAs (as per identified \u00a0 \u00a0 subject matter expert\/s).
\n\tEnsuring accurate and \u2018real-time\u2019 filing of training records.
\n\tEnsuring \u2018real-time\u2019 maintenance of TrackWise\/QAlign records.\u00a0
\n\tEnsuring that relevant documentation requested by auditors is provided in a timely manner during internal and external audits.
\n\tEnsuring that training records are up to date to ensure audit readiness.
\n\tEnsuring that the commercial team members are trained on those RA:SQC procedures where there are shared responsibilities.<\/p>\n
GENERAL<\/p>\n
\tEnsuring systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs.
\n\tAdherence to agreed Key Performance Indicators (KPIs).
\n\tSupporting the continuous development and improvement of the Medical Information and Compliance function while upholding Aspen core values.
\n\tEnsuring relevant records are maintained as soft copies and hard copies, as per Pharmacare filing structure\/instructions.
\n\tAdherence to Company Health & Safety procedures.
\n\tParticipation in training programmes.\u00a0
\n\tTo provide a leadership role as required by taking responsibility for specified areas and coaching of staff.
\n\tAny other duties as assigned by Manager.<\/p>\n
Requirements
\nEDUCATIONAL REQUIREMENTS<\/p>\n
\tBachelor of Pharmacy Degree and registration with the South African Pharmacy Council<\/p>\n
KNOWLEDGE AND EXPERIENCE REQUIREMENTS<\/p>\n
\tMinimum 1 to 2 years\u2019 pharmaceutical experience
\n\tExperience in Medical Information is an advantage
\n\tAbility to work with multi geographical locations & time zones
\n\tExperience in medicine legislation and related guidelines and codes of practice preferable
\n\tRegulatory Authority requirements\/legislation
\n\tUnderstanding of the laws and requirements governing the marketing of medicines and printed packaging Guidelines and codes of practice
\n\tUnderstanding requirements of medical information and information management
\n\tTerminology \u2013 understanding the jargon
\n\t\u00a0Understanding business processes
\n\t\u00a0 Product knowledge
\n\t\u00a0 Industry knowledge
\n\t\u00a0 Dossiers and requirements
\n\t\u00a0 Multilingualism (including Afrikaans) would be an advantage<\/p>\n
SOFT SKILLS REQUIREMENTS<\/p>\n
\tIntegrity, good work ethic and ability to meet deadlines
\n\tSelf-starter
\n\tAnalytical and planning skills
\n\tAccuracy and attention to detail
\n\tEffective organisational skills and ability to prioritise
\n\tAbility to work under pressure and to tight deadlines
\n\tAbility to work in a fast-paced international environment
\n\tAbility to manage projects in a matrices team environment and \u00a0with both internal and external partners
\n\tWilling to travel if required
\n\tPresentation skills
\n\tTime management skills
\n\tService orientation
\n\tDecision making skills
\n\tCustomer focused
\n\tSelf-confidence
\n\tOrganisational awareness
\n\tInformation seeking
\n\tExcellent interpersonal and communications skills
\n\tA solutions provider
\n\tManage evolving deadlines effectively with regular feedback \u00a0and updates
\n\tEnthusiasm and drive to take ownership and drive process \u00a0initiatives
\n\tLogical thinking
\n\tPositive \u2018can \u2013 do attitude\u2019
\n\tWork autonomously and have good problem-solving skills
\n\tHonest and trustworthy
\n\tRespectful and highly personable
\n\tPossess cultural awareness and sensitivity
\n\tFlexibility and confidentiality
\n\tEmpathy, patience, influence
\n\tSense of urgency
\n\tPositive and pro-active approach to business tasks
\n\tBusiness process analysis
\n\tReport writing
\n\tInformation gathering and monitoring
\n\tProjects (advantage)<\/p>\n
\u00a0COMPUTER SKILLS REQUIRED<\/p>\n
\tEffective use of appropriate IT systems and programs\u00a0<\/p>\n
go to method of application \u00bb<\/p>\n
Apply via company website ( ) or<\/p>\n
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