Pharmacovigilance Scientist

**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 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. To provide support to the Pharmacovigilance Lead for the various Pharmacovigilance operations, in particular the medical and scientific functions with respect to safety evaluations of all Aspen products across Pharmacare and any other entity owned by Aspen, of the Aspen Group for which marketing authorizations are held. The role undertakes responsibility for coordinating and management of review and analysis of aggregate safety data concerning the Aspen Group product portfolio.

**KEY RESPONSIBILITIES**

**K**e**y Accountabilities**
- Delegated tasks from RA Manager or PV Lead on a defined and ad hoc basis with the flexibility of mind-set and time resource this entails. This will include representation at meetings when required.
- Functional reporting: Mentoring of the Pharmacovigilance Officers and Medical Writers.
- Review and advice regarding relevant local and global guidelines, policies, internal procedures and SOPs across Aspen Pharmacare.
- Maintain awareness of Pharmacovigilance regulatory requirements and developments.
- Manage outsourced data collection, organisation and preparation with vendors.
- Act as Subject Matter Expert (SME) in designated area (e.g. literature, signal management, aggregate reports, labelling etc.) responsible for oversight and coordination of tasks related to the area of expertise.
- Preparation of annual as well as ad-hoc and scheduled aggregate safety reports.
- Ensure Good Documentation Practice.
- Contribute to agreed PV Team quality and compliance targets.
- Serve in a leadership capacity for complex and strategically important Pharmacovigilance developmental programs.
- Direct interaction with Regulatory Authorities.

**F**inancial**
- Identification of project challenges to departmental line management and the financial impact thereof.
- Project management of contractual and financial aspects of all medical writing projects and the effective utilisation of resources to keep processes cost-effective.

**Medical Writing Accountabilities**
- Work in collaboration with Medical Writers to write clinical documents for submission to regulatory authorities, including but not limited to:

- clinical overviews and summaries
- integrated summaries of safety and efficacy
- Clinical Expert Statements
- Provide medical editing review of draft and final documents prepared by other team members before internal or external distribution. This includes both copy editing and content review.
- Ensure document content and style adheres to SAHPRA/FDA/EMA or other appropriate regulatory guidelines and comply with Aspen SOPs and style guidelines.
- Perform literature searches/reviews as necessary to obtain background information and training for development of documents.

**S**afety**
- ICSR (Individual Case Safety Reports)
- Ensure all cases are processed, medical reviews completed, and cases submitted to Health Authorities as per the timelines specified in the guidelines.
- Ensure quality checks are performed on weekly, monthly, quarterly and bi-annual reconciliations with internal and external stakeholders.
- Labelling
- Updating and reviewing Product Information in line with the Company Core Data Sheets, and other tasks as designated.
- Aggregate Reporting