Pharmacovigilance Lead and Local Responsible Person for Pharmacovigilance - Aspen Pharma Group - Johannesburg

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. OBJECTIVE 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 as the Local Responsible Person for Pharmacovigilance (LRPPV) for coordinating and managing the Regulatory Pharmacovigilance requirements for the New Product Launch Pipeline and the existing product portfolio in the region, through the management and implementation of the South African and SADC Regulatory Plan for a defined portfolio of products. This includes all Regulatory Authority requirements relating to Pharmacovigilance and safety for Aspen and Alliance Partner products, including Pharmacovigilance inspections, ensuring that adequate procedures and systems are in place for the Pharmacovigilance activities to be carried out at Pharmacare in line with global and local regulations. To provide support to Regulatory Affairs Manager: Safety, Quality and Compliance, Pharmacare or HOD or Executive in the management of Aspen Pharmacovigilance (PV) Department which acts as affiliate PV hub for Aspen Group products and Pharmacare IP in the region. Manage tasks from Regulatory Affairs Manager: Safety, Quality and Compliance, Pharmacare HOD or Executives on a defined and/or ad hoc basis. To provide leadership, training and support to pharmacovigilance team. KEY RESPONSIBILITIES Local Responsible Person for Pharmacovigilance Delegated as the Qualified Person for Pharmacovigilance in South Africa and other SADC territories (where applicable). Responsible for the maintenance of the local pharmacovigilance system. Act as a single point of contact for the Authority on all matters relating to pharmacovigilance and safety of Pharmacare and Contractual Partner products including pharmacovigilance inspections. Act as the interface with any Strategic Partners / Alliance Partners in relation to all pharmacovigilance and safety-related activities to ensure that systems and processes are put in place to enable integration and alignment, including strategic projects where relevant. Project Management Ensure a process is in place for risk assessment for any significant changes to existing product portfolio or systems. Develop a framework for setting internal and external deliverables against each medical writing project for the region, to include project goals and objectives and measurement criteria and business outcomes for each project goal. Project management of contractual and financial aspects of all medical writing projects and the effective utilisation of resources to keep processes cost effective. Identification of project challenges to departmental line management and the financial impact thereof. Procedures and Systems Maintain awareness of local and global PV regulations and assist Regulatory Affairs Manager: Safety, Quality and Compliance, Pharmacare or Executives in review and implementation of relevant company policies and procedures. Assist Regulatory Affairs Manager: Safety, Quality and Compliance, HOD or Executives to ensure that there are adequate procedures and systems in place for PV activities conducted at Pharmacare which include: Receipt, processing, follow-up and reporting of individual case safety reports (ICSRs) Signal Management Aggregate Reports Risk Management System Local Literature review Management of Safety Data Exchange Agreements (SDEA) Maintenance of the Pharmacovigilance System Master File (PSMF) Maintenance of the core clinical and nonclinical modules Maintenance, update and roll-out of the Company Core Data Sheet (CCDS) Creation and Update of Product Information for Pharmacare territories Responding to Safety Related Information Requests from Regulatory Authorities Handling of Urgent Safety Restrictions Dear Healthcare Professional (DHCP) Communications Quality Management and Compliance Monitoring Recall & Product Withdrawal Evaluate evidence or information to determine whether an ADR/AE/Quality Defect or similar necessitates a possible Product Withdrawal or Product Recall. Coordinate safety related recalls in cooperation in QA and competent authorities in line with company procedures and country specific regulations. Ensure that a ‘mock recall’ occurs annually to test current procedures or when significant change in staff is made or significant change in recall procedure is implemented. Ensure that all records of all product recalls and ‘mock recalls’ are retained for a period of 7 (seven) years Receipt, processing, follow-up and reporting of individual case safety reports (ICSRs) Assist the Regulatory Affairs Manager: Safety, Quality and Compliance, HOD, or Executives with oversight of the receipt, processing, follow-up and reporting of individual case safety reports (ICSRs) to ensure compliance with company procedures and regulations. Signal Management Oversight of the signal management process including the signal management schedule to ensure that all potential safety concerns are prepared and evaluated in a timely manner in line with SOPs and regulations. Review and approval of case series review or signal assessment reports. Aggregate safety reports Oversight of the aggregate reports process including the global aggregate reports schedule to ensure that all relevant reports are prepared in a timely manner in line with SOPs and local regulations. Review and approval of aggregate safety reports. Risk Management System Oversight of the development, implementation and maintenance of the risk management system in line with company SOPs and regulations. Review and approval of risk management plans (RMPs). Literature Search Assist the Manager, HOD or Executives to ensure that SOPs and systems are in place to conduct the local and global literature searches in order to detect ICSRs and relevant safety information. Assist the Manager, HOD or Executives to ensure that Affiliates or Vendors are in place to conduct local literature searching to detect ICSRs and relevant safety information. Management of Safety Data Exchange Agreements or other PV Agreements Assist Manager, HOD or Executives to ensure that there are relevant agreements in place between Aspen and all Affiliates, Vendors and Partners that handle safety information incl. ICSRs on behalf of Pharmacare PV. Have oversight of all agreements. Pharmacovigilance System Master File (PSMF) Assist Manager, HOD or Executives to ensure the PSMF is maintained in line with company procedures and relevant regulations and guidelines. Ensure that the information contained in the PSMF is an accurate and up-to-date reflection of the pharmacovigilance system. Maintenance of the clinical and nonclinical CTD Modules Management of the creation and maintenance of the core nonclinical and clinical modules in line with company procedures and country specific guidelines (where relevant). CCDS and Product Information Oversight of implementation of the CCDS for Aspen Group Products and where Pharmacare is responsible for maintaining and/or rolling out the CCDS, as well as licence partner CCDS obligations. Responding to Safety Related Information Requests (RFIs) from Regulatory Authorities Oversight of all safety related regulatory queries that arise or are raised pertaining to Pharmacare products. Review and approval of safety related regulatory queries. Urgent Safety Restrictions (USRs) Examine safety signals or issues to determine whether a USR is warranted. Ensure coordination, management and documentation of all activities relating to USRs in line with company procedures and country specific regulations. Direct/Dear Healthcare Professional (DHCP) Communication and Competent Authority Communication Evaluation of evidence or information to determine whether a change to the safety profile or supply issues requires a DHCP letter. Coordination of the creation and dissemination of a DHCP letter in line with SOPs and local regulations. Review all DHCP letters. Organised Data Collection Systems (ODCS) PV evaluation of agreed ODCS for impact on patient safety and to determine whether a risk assessment or partner agreements are required. Oversight of all Organised Data Collection Systems that are conducted by or on behalf of Pharmacare. Quality Management and Compliance Monitoring System Assist Manager, HOD, or Executives in oversight and review of periodic quality and compliance metrics for ICSRs, Aggregate Safety Reports, Safety Related RFIs, Signal Management, CCDS, Safety Variations to ensure that processes and regulations are being adhered to. Review and approve deviations and CAPAs where required. PV Management and Training Assist Manager, HOD or Executives in ensuring that Pharmacare PV staff and relevant Partners and Affiliates are adequately trained in handling of safety information for Pharmacare products including ICSRs. Assist Manager, HOD or Executives in ensuring that training is adequately documented and kept up to date for Pharmacare PV staff. Direct, support and lead outcomes of clinical trials provided by the PV team. Plan and manage development of PV team. Audits and Inspections Assist Manager, HOD or Executives in preparation of and input into Regulatory Authority inspections of Pharmacare or Partners. Assist Manager, HOD or Executives in ensuring that Partners and Affiliates responsible for performing PV tasks or handling safety data are regularly audited. Team Management Create ways of doing things differently and more effectively within the department. Challenge current ways of working with a view to suggesting more effective and efficient processes. Accomplish staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching, counselling, and disciplining employees; developing, coordinating, and enforcing systems, policies, procedures, and productivity standards. 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 effective. Adherence to Company Health & Safety procedures. Participate in training programmes. Any other duties as assigned by RA Manager. Manage clinical trials for the PV area of the region. EDUCATION & EXPERIENCE: Healthcare professional with Medicine, Pharmacy or other healthcare professional degree recognized by the Authority. 7 years’ experience in the pharmaceutical industry Minimum of 5 years’ PV/Drug Safety experience in the Pharmaceutical Industry Management or Supervisory experience essential Experience in Argus Safety database would be an advantage Clinical trial experience advantageous KNOWLEDGE: Clinical research Pharmacovigilance regulations Knowledge of MedDRA and WHO drug coding Adequate theoretical and practical knowledge of all areas of pharmacovigilance Documented experience in all aspects of pharmacovigilance MS Office SKILLS AND ATTRIBUTES: Integrity Work ethic Ability to meet deadlines Excellent oral and written English communication Detail oriented and work with a high degree of accuracy Highly organized and flexible Above average computer skills Decision making Problem solving Service orientation Time management Process driven Manage evolving deadlines effectively with regular feedback and updates Collaborative, team approach Performance driven Tenacious Intuitive Proactive Patient Logical, critical thinker Interpersonal and cultural sensitivity Empathy Integrity Enthusiasm and drive to take ownership and drive process initiatives Occasional travel is part of the job 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 14 March 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 Apply Now

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Pharmacovigilance Lead and Local Responsible Person for Pharmacovigilance - Johannesburg

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