OBJECTIVE OF ROLE

• 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 Authorization 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 with Regulatory bodies, affiliates, and partners within the stipulated timelines

KEY RESPONSIBILITIES

 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 prioritization 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 (Track-wise).

Reconciliation

• Reconciliation of all adverse event reports received by PV from internal stakeholders (QA/MI and ACC).
• Reconciliation of all adverse event reports received from PV service providers, affiliates, distributors, and license partners monthly, quarterly, or biannually as described in the Safety Data Exchange Agreement (SDEA).

Quality Systems Management

• Support preparation of SOPs, WIs, and product safety reviews
• Raising 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 Track wise.

   Aggregate Reporting and Regulatory Intelligence

•   Keeps abreast of changes to PV Legislation and ensures Regulatory Intel is monitored for ZA and SSA 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 key Medical Journals for any adverse drug reaction reports with Aspen Pharmacare products/medicines.

Understand SDEA obligations in order to ensure all aspects of the 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)
• Review 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’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 Global PV Global.

CUSTOMER SERVICE

• All queries are followed up and strictly within the policy framework, i.e., 48 48-hour turnaround time.
• A professional attitude is displayed when responding to a customer’s needs.
• Methods for improving customer service 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’s core values
• Effective management and utilization of resources to keep processes cost-effective
• Collating data for ad hoc requests
• Adherence to Company Health & Safety procedures
• Participate in training programmes
• Any other duties assigned by your manager

Requirements
EDUCATIONAL REQUIREMENTS

• Bachelor’s or postgraduate degree in science, pharmacy, or medicine, or Post Basic Pharmacist Assistant

KNOWLEDGE & EXPERIENCE REQUIREMENTS

• PV experience (2 years), experience in post-marketing reporting of AEs.
• Quality Assurance experience (1 year).
• GCP training is advantageous.
• 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.

SOFT SKILLS REQUIREMENTS

• Business process analysis
• Report writing
• Information gathering and monitoring
• Projects (advantage)
• Ability to communicate information effectively and clearly in written form and 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 confidentiality
• Positive and proactive approach to business tasks
• Enthusiasm and drive to take ownership and drive process initiatives