Job title: Medical Information and Compliance Officer (Temp)
Company: Aspen Pharmacare
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 Group’s key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands. We have approximately 9,100 employees at 69 established offices in over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable medicines.
OBJECTIVES: 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 South Africa and the 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.
KEY RESPONSIBILITIES
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.
EDUCATION & EXPERIENCE
- Qualified Post Basic Pharmacist Assistant or Post Graduate degree in science.
- 5 years plus in a retail/hospital/pharmaceutical/healthcare environment.
- Working with and according to contracts and/or tenders.
- Advanced computer experience (Application Software Packages, Data Capturing, MS Office (all programs).
KNOWLEDGE
- 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.
SKILLS AND ATTRIBUTES
- 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.
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 30 August 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 applications.
Expected salary :
Location : Johannesburg, Gauteng
Job posting date : Fri, 23 Aug 2024 01:23:12 GMT
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