Pharmacovigilance Officer

4 weeks ago

Johannesburg, South Africa Aspen Pharma Group Full time

**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 careers 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 the 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 (PV) function of the SA Regulatory Affairs department in the receipt, assessment, processing and reporting of Individual Case Safety reports (ICSRs) in accordance with PV procedures and PV legislation by ensuring compliance is met with Regulatory bodies, affiliates and partners within the stipulated timelines.

**KEY RESPONSIBILITIES**:

- 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 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).
- 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.
- Keep abreast of changes to PV Legislation and ensure Regulatory Intel is monitored for ZA and SADC territories.
- Contribute to the development of PV training.
- Pharmacovigilance training of all Aspen employees and distributors/service providers and documentation thereof.
- Regulatory review of key Medical Journals for any adverse drug reaction reports with Aspen Pharmacare products/medicines.
- Facilitate SDEA training (to employees as well as 3rd parties).
- Coordinate Safety Review meetings (monthly).
- Reviewing of Regulatory websites for any potential signals.
- Aggregate Reporting and Regulatory Intelligence.
- Basic PV training for all Aspen employees.
- Literature reviews
- Understand SDEA obligations to ensure all aspects under agreements are duly executed.
- 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's 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 Group PV.
- All queries are followed up and strictly within the policy framework i.e. 48 Hours turn-around time.
- A professional attitude is displayed when responding

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