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 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, outsourcing, and relevant licensors and distributors.
• Identification of project challenges to departmental line management and the financial impact thereof.
• Ensure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs.
• Effective management and utilisation of resources to keep processes cost-effective.
• Collating data for ad hoc requests.
• Adherence to Company Health & Safety procedures.
• Participate in the training programme.s
• Any other duties as assigned by your Manager.

Requirements
EDUCATION & EXPERIENCE:

• Bachelors or Post Graduate degree in science, pharmacy or medicine, or Post Basic Pharmacist Assistant
• PV experience (1 -2 years);
• experience in post-marketing reporting of AEs;
• Quality Assurance experience (1 year);
• GCP training is advantageous.

KNOWLEDGE:

• Knowledge of relevant information sources including printed publications, unpublished sources, databases, websites, social media sites and external bodies;
• Effective understanding and use of the principles of information capture, storage, searching and retrieval;
• Effective use of appropriate IT systems and programs;
• Understanding of relevant legal and related issues on copyright, codes of Practice, Data Protection legislation, regulations and guidelines.

SKILLS AND ATTRIBUTES:

• Business process analysis.
• Report writing.
• Information gathering and monitoring.
• Ability to communicate information effectively and clearly in written form orally, and at levels appropriate to the needs of different internal and external customers.
• Integrity.
• Work ethic.
• Ability to meet deadlines.
• Positive ‘can–do attitude’.
• Work autonomously and have good problem-solving skills.
• Able to cope with evolving deadlines effectively with regular feedback and updates.
• Honest and trustworthy.
• Respectful and highly personable.
• Possess cultural awareness and sensitivity.
• Flexible and confidential.
• A positive and proactive approach to business tasks.
• Enthusiasm and drive to take ownership and drive process initiatives.