Pharmacovigilance Lead and Local Responsible Person

**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 Informat