Current Vacancies at Aspen Pharma Group

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 ad hoc requests
• Adherence to Company Health & Safety procedures
• Participate in training programmes
• Any other duties as assigned by your Manager

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.

Requirements

EDUCATION & EXPERIENCE: 

• Matric
• 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.
• 1 Year Quality Assurance experience 
• GCP training advantageous 

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MAIN DUTIES

FINANCIAL

• Effective utilization of resources to keep processes cost effective.

CUSTOMER

• Display a professional attitude when responding to customers.
• Propose, develop and update methods to improve customer services.
• Effective liaison and communication with internal and external customers, including but not limited to Regulatory Authorities, external consultants and agents, Quality Assurance, Project Managers, Artwork, New Product Launches, Manufacturing sites, Pharmacovigilance, Medical Information, AGI, APTL

SYSTEMS, DATABASES AND TRACKERS

• Initiate change controls and action items in Quality Management System
• Track medicinal samples for registration submissions and development work.
• Identify, track, and manage free space available in safes.
• Track internal and off-site archiving.
• Enter SMF information onto relevant databases.
• Utilise systems, databases, and trackers to provide accurate information to internal and external customers on request.

ADMINISTRATIVE

• Type, print, copy, scan and bind documents.
• Retrieve from and return IP to safes.
• Create, label and archive files.
• Receive Local Document Archiving Forms. Allocate space for new files in the safes and update IP Database
• Ensure sufficient free space available in the safes, and if required, consulting with the line manager to identify which files can be archived off-site.
• Request payments and provide proof of payment to the requestor.
• Ensure delivery and/or collections to and from SAHPRA
• Arranging for drivers and maintain a delivery/collections log.
• Ensure proof of receipt of SAHPRA submissions and correct filing
• Send parcels (documents, samples, CD’s etc.) and supportive documentation to Regulatory Authorities, agents and/or other Aspen departments via courier
• Assist in updates of SOP’s, working instructions, forms, templates as they relate to the administrative functions of the department
• Provide training on administrative procedures to new/existing personnel
• Maintain hard copy and electronic training matrix, training records and training files
• Arrange meetings, training, functions, venues, catering
• Manage meeting agendas and take minutes
• Receive and collate monthly reports
• Receive, collate, and submit leave forms, overtime forms, expense claims, timesheets, invoices
• Maintain and managing team lists e.g. birthdays, half days, working hours, employee numbers
• Assist with induction process for new employees
• Order stationery and stock the stationary cupboard
• Remove documents for shredding

OFF-SITE ARCHIVING

• Request retrieval of boxes from off-site
• Track movement of products removed from boxes, and ensuring requestor signature
• Track on-site stock of boxes from off-site
• Ensure product information is returned, sealed and then returned off-site

MEDICATION SAMPLES

• Log temperatures of both medication storerooms daily and record deviations
• Pack expired medicinal stock for destruction according to process and track accordingly
• Order, receive and track medicinal samples for investigational and registration purposes as required
• Notify relevant personnel of receipt of samples as per process

SITE MASTER FILES

• Print and submit Site Master Files (SMFs) to SAHPRA
• Record SMF information on relevant network drive/systems
• Liaise with SAHPRA on the allocation of an SMF number
• Send notification of submission/receipt of SMF numbers to the relevant personnel as per process

REGULATORY SUPPORT

• Supersede dossiers for specific regulatory activities as per departmental working instruction 
• Ensure relevant history/status documents are updated
• Source regulatory information from dossiers, under supervision
• Compile follow up letters/extension requests and submit to the Regulatory Authorities
• Compile post-screening copies as required by SAHPRA, and submit
• Send notification of submission to relevant stakeholders
• Post-registration administrative activities of newly registered products
• Ensure regulatory submissions are signed by a pharmacist

GENERAL

• Maintaining electronic folder structure as per departmental procedures
• Comply with regulations, guidelines, policies, procedures, and work instructions
• Adhere to deadlines/due dates
• Provide feedback to pharmacist’s/line manager once tasks are completed
• Escalate possible risks, critical issues which could result in delayed submissions

LEARNING AND GROWTH

• Training and development identified and planned with the line manager
• Training is implemented according to ongoing personal and team development plans
• Up-skilling and multi-skilling are coordinated in line with staff development.

EDUCATION & EXPERIENCE

• Matric/Grade 12
• Must be proficient in Word, Excel, Outlook
• Experience with administrative work (2 years)
• Knowledge of pharmaceutical industry/regulatory affairs

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Main Duties:

• Effective management of Independent Key Accounts, including Wholesalers and selected Customer Groups while establishing an environment and foundation for current & future selected sales growth.
• Execute SLA’s and Logistics agreement as agreed upon and accepted by both parties. Ensure monthly services are received as per the SLA and remediated back for Audit.
• To lead the analyses, development, implementation, and measurement of all commercial initiatives linked to increasing market share at an Independent Key Account level. 
• To combine strategic, analytic and core key independent customer management skills across a variety of therapeutic areas and baskets, to improve and maintain Aspen market share at an Independent Key Account level.
• Conducting monthly sales analysis with Wholesalers / Independent groups and monitoring orders.
• Timeous submission of SLA Invoices for payment or SLA’s Promotions, claims etc
• Approve and manage short-dated stock claims.
• Listings of new product launches and submission of product codes to be loaded on Repwise
• Accurate Sales forecasting through monthly sales assumption/prediction vs budget to be achieved and used as cornerstone for stock replenishment.
• Timeous submission of Stack up forecasts & related demand numbers.  

Manage stock levels at wholesalers to an optimum level.

• Ensure adequate stock levels are kept at optimal levels in the Key Independent Wholesaler Accounts in order supply generated on an Independent pharmacy level. 
• Communicate & manage excess and insufficient stock levels, by implementing commercial drives to reduce excess stock levels. 
• Communicate and collaborate with the wholesale buyer to replenish insufficient stock.
• Close co-operation and communication with Supply Chain.

Effective management of resources

• To manage allocated Sales & Commercial budgets, through effective co-ordination of sales activities and commercial behaviours against an allocated budget, on a national level

Develop and maintain excellent relationships with Key Customers.

• Conduct detailed business reviews and offer solutions in line with a customer’s objectives and environment. Maintaining a deep understanding of customer needs and monitor their preferences.
• Resolve escalated customer queries in line with company policies.
• Develop manage, and maintain industry contacts with decision makers and influencers, building strong customer relationships to ensure maximum satisfaction, and increased market share

Requirements

Qualification & Experience:

• Matric/Grade 12 Certificate
• Sales or Marketing qualification will be an advantage.
• Min 5 years Key Account Management experience obtained from Independent Pharmacy and / or Wholesale channel.
• Sales management experience will be an advantage.
• Must be proficient in MS Office: Excel, PowerPoint, outlook, and Word 
• Valid code 8 license and own transport
• Exposure & knowledge of local pharma markets (including policies & processes).

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Responsibilities

Training development

• Develop curricula for specific roles, in collaboration with departmental management and support functions.
• Develop material for training programs and review, evaluate and modify existing and proposed programs.
• Develop relevant assessment tools, on the job observations (practical observations) and job aids.

Training planning and administration

• Prepare and administer site training programs.
• Plan and track training activities
• Coordinate with managers and SMEs to ensure software and equipment training are up to date and content is aligned with SOPs and departmental / technical requirements.
• Maintain training records for employees in production area and report on training activities, as required.
• Ensure compliant documentation is kept of training activities.
• Support and assist other departmental work when necessary to maintain current understanding of needs.

Training facilitation

• Conduct training programs and sessions, as applicable to the production area
• Train on applicable procedures and processes as per regulatory requirements
• Administer and evaluate training assessments.
• Assess and evaluate on the job application after completion of the training.
• Put measures in place to address competency gaps after the training.
• Deliver topic specific training as required.
• Understand and train on applicable procedures and processes required in regulatory requirements.

Requirements

Background/experience

• 6 years' relevant experience
• Practical experience in a relevant technical field
• Pharmaceutical industry experience and/ or experience working in a laboratory environment.
• Understanding of training procedures and techniques
• National Diploma in relevant technical field (Pharmacy/Chemistry/Biomedical Science/ Engineering), or a related discipline.

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KEY PERFORMANCE AREAS

• Actively maintains recognized expert level knowledge in two or more identifiable business application specialisms. 
• Provides definitive and expert advice in their specialist area(s) but able to apply their specialism using a systems and design thinking approach. 
• Oversees the provision of specialist advice by others, consolidates expertise from multiple sources, including third party experts, to provide coherent advice to further organizational objectives.
• Leads the development of application solution architectures in specific business, infrastructure or functional areas.
• Ensures that appropriate tools and methods are available, understood and employed in application architecture development.
• Within a change programme, leads the preparation of technical plans and, in liaison with business assurance and project staff, ensures that appropriate technical resources are made available.
• Provides advice on technical aspects of solution development and integration (including requests for changes, deviations from specifications, etc.) and ensures that relevant technical strategies, policies, standards and practices (including security) are applied correctly.
• Selects, adopts and adapts appropriate software design methods, tools and techniques; selecting appropriately from predictive (plan-driven) approaches or adaptive (iterative/agile) approaches.
• Specifies and designs large or complex software components. Undertakes impact analysis on major design options, makes recommendations and assesses and manages associated risks.
• Specifies prototypes/simulations to enable informed decision making.
• Evaluates the quality of others' systems designs to ensure adherence to standards and identifies corrective action, if needed.
• Ensures that the system design balances functional, quality, security and systems management requirements.
• Contributes to development of organizational software design and architecture policies and standards.
• Identifies, evaluates and manages the adoption of appropriate tools, techniques and processes (including automation and continuous integration) to create a robust integration framework.
• Leads integration work in line with the agreed system and service design.
• Monitors and reports on the results of each integration and build.
• Designs and builds integration components and interfaces.
• Contributes to the overall design of the service and the definition of criteria for product and component selection.
• Contributes to development of systems integration policies, standards and tools.
• Drafts and maintains procedures and documentation for applications support.
• Manages application enhancements to improve business performance. 
• Advises on application security, licensing, upgrades, backups, and disaster recovery needs. 
• Ensures that all requests for support are dealt with according to set standards and procedures.

JOB REQUIREMENTS

Educational qualifications & experience

• Matric / Grade 12.
• B.Com / BSc Computer Science degree or equivalent work experience .
• Current industry certification in architecture (i.e., TOGAF, Zachman, etc.).
• Operational Management Methodology (i.e., ITIL, COBIT, SDLC, DevOps, Agile).
• 10+ years’ experience of managing relationships with internal business customers and supply chain business processes.

Specific experience, knowledge and registrations 

• Experience and sound knowledge of Application development and Implementation/Release management, implementation and improvement practices.
• ERP (SAP), IBP, JustEnough, Kinaxis or similar Supply Chain Management Systems.
• Business Applications – Capability based model (MIS, SCM, etc).
• 10+ years’ experience managing application management and automation in a large complex/matrix global organisation.

Work-specific skills & exposure

• 10+ years’ experience leading teams, internal and 3rd parties in a multivendor approach.

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Responsibilities:

Financial

• Effective utilization of resources, relating to self and team members to keep processes cost effective
• Ensuring correct allocation of payments preventing over payment
• Cashbook and ledger interface to SAP

Customer Service

• Manage all salary and benefit queries according to divisional requirements.
• Customer queries are dealt with in line with the customer service philosophy.
• Regular feedback sessions are held with the customer to ensure continual improvement.

Continues Improvement Processes

• Capture / calculate payments, input into payroll. 
• Attend to Garnishee Order queries from attorneys.
• Check all payroll input for monthly payroll.
• Check payroll for correctness on completion of the running process by the Payroll Supervisor.
• Prepare manual ad-hoc payments to staff members.
• On completion of the payroll run and distribute reports.
• Create & produce payroll reports on request.
• Issue duplicate IRP5 certificates on request.
• Attend to salary queries from staff members.
• Filing/Scanning.
• Keep up to date with Legislative changes impacting the payroll environment.

Payroll Administration

• Capture, calculate and ensure accurate processing of payroll from input to output.
• Completion and submission of unemployment insurance forms and Declaration file.
• Provident fund, PAYE EMP 201 and Directives to be submitted accurately.
• Monthly recons to be created, reconciled and submitted e.g. Med Aid, PAYE, SARS Balancing etc.

Banking

• Create EFT’s for salaries and 3rd party payments.
• Ad hoc payments.

Management Of Leave

• Attend to all leave administration, filling, capturing, scanning and recons, etc.
• Monthly and Quarterly audits.
• Maintain DIY Leave box.

Requirements

Qualifications And Experience

• Matric / Grade 12
• Payroll Qualification
• Minimum 5 years payroll system experience (CRS will be advantageous)
• Experience of financial applications

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To be considered for this opportunity, applicants must meet these minimum requirements:

• Must have a completed Degree/ BTech in Human Resources or Industrial Psychology   
• Be computer literate (Microsoft)
• South African Citizen 
• No current or pending disciplinary incidents