Job Detail ROLE PURPOSE: To support the SA Commercial Business to realize 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. The role undertakes responsibility for compliance with the Regulatory / Pharmacovigilance 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. Plays an integral role in supporting the Regulatory Affairs Department (PV function) with administrative duties. Acts as a liaison between different stakeholders, supporting and enhancing Regulatory Affairs administrative processes. This will include administrative tasks relating to Pharmacovigilance, quality management systems, labelling submissions and ad hoc project management MAIN DUTIES QUALITY MANAGEMENT SYSTEM (QMS) Compiling and maintaining Standard Operating Procedure (SOP) and Work Instruction (WI) documents for all administrative functions. Assisting with the compilation and maintenance of departmental procedural documents. Maintenance of employee training files. Accurate retrieval of information/documentation during audits. Performing a monthly GAP analysis and monthly reporting on outstanding issues on the QMS. Monitoring of Trackwise records in real time Raising and monitoring of change controls in Trackwise. Providing weekly reports on the status of Trackwise records and ensuring timeous closing of all records. REGULATORY SUPPORT (LABELLING) Assist with administrative tasks Retrieval and return of IP from safes ADMINISTRATIVE SUPPORT Efficient, effective tracking, recording, filing and submitting AGI timesheets. Organizing of functions. General administrative work and support to the pharmacovigilance staff. AD HOC PROJECT MANAGEMENT Management of allocated (administrative or other) projects within PV. GENERAL Ensure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs Adhere to agreed Key Performance Indicators (KPIs). Support the continuous development and improvement of the PV function while upholding Aspen core values. Effective management and utilisation of resources to keep processes cost effectiv Adherence to Company Health & Safety procedures. Participation in training Programmes Skills and Attributes: Integrity, good work ethic and ability to meet deadlines Conflict resolution Attention to detail Listening Problem resolution Time management Computer literate Decision making Logical thinking Accuracy Good judgement Positive attitude Customer focused Inter-personal sensitivity Cultural sensitivity Information seeking Knowledge: Pharmaceutical industry MS office applications, Adobe Acrobat, Excel Experience in Quality Management Systems e.g. Trackwise, Veeva Vault Quality Docs Education & Experience: Matric / Grade 12 Post Basic Pharmacist assistant qualification will be an advantage Minimum of 2 years’ experience in an office environment preferably in a Pharmacovigilance or Medical Affairs setting Secretarial/office administration qualification an advantage 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 09 . 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 entity that will employ the successful candidate. If you have not heard from the HR department within 30 days of this advert closing, please consider your application unsuccessful. Internal Applications must be completed using an Aspen mailing address after applicants have had informed their direct line managers of their application.