Job Description

COMPANY DESCRIPTIONWe 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 Groups 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.OBJECTIVES: 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 (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 RESPONSIBILITIESPHARMACOVIGILANCE 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.
• Managing and prioritising 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 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 the policy framework i.e. 48 Hours turn-around time.
• A professional attitude is displayed when responding to a customers 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.

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 SOPsAdhere 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 utilisation 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 as assigned by your Manager.

EDUCATION & EXPERIENCE

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

Aspen is committed to the principles of equal employment opportunity and suitably qualified job applicants are invited to submit their CV online on or before the 22 August 2024. Preference will be given to applicants from designated groups through a fair recruitment and selection process in accordance with laws governing employment equity, where such laws are applicable to the AspenInternal Applications must be completed using an Aspen mailing address after applicants have had informed their direct line managers of their applications

Aspen Pharmacare