Pharmacovigilance Officer

**Company Description**:
We are a global speciality 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.

**MAIN DUTIES**

**PHARMACOVIGILANCE SUPPORT**
- ICSRs (Individual Case Safety Reports)
- Performing assessment of adverse event case reports.
- Act as case owner for assigned ICSRs to ensure accurate completion of data entry (DE), data review (DR) and regulatory reporting (RR), in line with current SOPs.
- The PVO acts as a product owner for products under the remit of Pharmacare, supporting the PV Scientists with literature management and aggregate report preparation.
- Maintain a high standard of case quality.
- The PVO is responsible for providing a root cause analysis for any late reporting submissions.
- Management and prioritisation of individual workload while maintaining good documentation practices (GDP).
- Highlighting any safety-related issues to the attention of the management team.
- Perform pharmacovigilance checks/evaluations of the Quality Assurance database (Trackwise Digital).
- Reconciliation
- Reconciliation of all adverse event reports received by PV from internal stakeholders (QA/MIC and ACC).
- Reconciliation of all adverse event reports received from PV service providers, affiliates, distributors and license partners monthly, quarterly or bi-annually as described in the Safety Data Exchange Agreement (SDEA).
- Quality Systems Management
- Support preparation of SOPs, WIs, and product safety reviews
- Raising of compliance cards for late cases reported to Pharmacare by service providers, affiliates, distributors and license partners.
- Ensure all allocated CAPAs, Deviations and Actions are closed on time on Trackwise Digital.
- Aggregate Reporting and Regulatory Intelligence
- Keep abreast of changes to PV Legislation and ensure Regulatory Intel is monitored for ZA and SADC territories.
- Basic PV training for all Aspen employees
- Contribute to the development of PV training.
- Pharmacovigilance training of all Aspen employees and distributors/service providers and documentation thereof.
- Literature reviews
- Regulatory review of key Medical Journals for any adverse drug reaction reports with Aspen Pharmacare products/medicines.
- Understand SDEA obligations in order to ensure all aspects under agreements are duly executed.
- Facilitate SDEA training (to employees as well as 3rd parties).
- Signal management
- Highlighting any safety-related issues to the attention of the management team
- Co-ordinate Safety Review meetings (monthly)
- Reviewing of Regulatory websites for any potential signals
- All other ad hoc PV activity duties as required by the business needs
- Adhere to agreed Key Performance Indicators (KPIs).
- Support the continuous development and improvement of the PV function while upholding Aspen core values.
- Receipt, evaluation and reporting of individual case safety reports in accordance with international (export territories) and local regulatory requirements and contractual partner obligations.
- Provide support to Global PV.

**CUSTOMER SERVICE**
- All queries are followed up and strictly within policy framework i.e. 48 Hours turn-around time.
- A professional attitude is displayed when responding to a customer’s needs.
- Methods for improving customer services are proposed.
- Internal and external customers are kept updated, under supervision, as to the progress of their queries
- Liaise on a daily basis with RA customers, i.e. SAHPRA, Marketing, Manufacturing sites, Quality-related departments, Public Health, Exports, Outsource, and relevant licensors and distributors.

**FINANCIAL**
- Identification of project challenges to departmental line management and the financial impact thereof

**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
- Collating data for