Jobs at Aspen Pharma Group

MAIN DUTIES

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: 

• 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 

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
• Respectful and highly personable
• Possess cultural awareness and sensitivity
• Flexible and confidentiality
• Positive and pro-active approach to business tasks
• Enthusiasm and drive to take ownership and drive process initiatives

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BASIC JOB FUNCTIONS (Brief Summary):

• Manage the operational activities of Active Pharmaceutical Ingredients (API’s) manufacturing according to the production plan and in accordance with the applicable quality management system requirements.
• Ensure that the product produced, in the production facility, conforms to the relevant quality and standards as they relate to customer demands and criteria, GMP, training, and OHSE matters.
• Optimise systems, processes, and procedures and ensure that plant resources are utilized effectively and efficiently
• Effectively and efficiently manage staff and handling of conflict
• Maintain GMP in the area with particular attention to documentation control, ERP, and general housekeeping
• Establish and maintain appropriate systems for operational management and measurement
• Comply with GMP requirements as outlined by Company SOP’s and written instructions in all tasks and activities
• Adhere to all Company OHSE rules and regulations
• Management of the company’s fire team
• Responsible for fire team training 
• Responsible for management of the site after hours
• Must be able to work shifts 

PERSONAL ATTRIBUTES (Brief Summary):

• Must be organized, hands-on, disciplined, and honest
• Must show good leadership skills and have an eye for detail and accuracy 
• Must be able to work and perform under pressure in a highly regulated environment
• Good interpersonal skills
• Good communication skills (written and verbal)
• Attention to detail

Requirements

JOB REQUIREMENTS:

• Grade 12 with Mathematics & Physical Science as subjects
• A desirable qualification encompasses a National Diploma and/or Btech in Chemistry or Chemical Engineering, or a comparable qualification compliant with the National Qualifications Framework (NQF)
• Must have 5 years of relevant experience in a chemical/pharmaceutical/manufacturing environment
• Experience in supervisory or leadership position would be advantageous
• Good working knowledge of cGMP (current Good Manufacturing Practice) and GDP (Good Documentation Practice) pertaining to the manufacture of Active Pharmaceutical Ingredients (API’s)
• Be trained as a fire fighter and take responsibility for fire training and an integral part of the emergency response team.

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Objective:

Develops, facilitates, and administers training programs for employees while assessing training and development needs for individuals and groups in order to develop their skills and knowledge. Training may take place on a face to face basis or virtual platform

KEY RESPONSIBILITIES

Execute, Implement, and Design quality training sessions in line with CHIETA accreditation requirements for interns and internal staff

• Facilitate, Design and Develop training material in accordance with qualification outcomes to ensure competency status is achieved.
• Perform an individual needs analysis before executing each training session with employees internally to identify gaps and ensure a robust plan is followed to reach competency levels.
• Assess all POEs to ensure they meet the requirements of CHIETA.
• To ensure learning material is updated every two years according to the outcomes of the qualification.
• Updating of monthly reports and trackers regarding competency status of learners with managers to address learning concerns or new educational needs regarding specific employees or departments.

Ensuring digital initiatives are designed in order for a blended learning approach to be adopted where necessary.

• Compile, develop, and design all learning material which is aligned to the business needs.
• Compiling all material to be integrated onto Partners the LMS platform and monitored by Training Manager.
• Training managers must ensure that training methods, content, software, systems, and equipment are appropriate and meaningful.
• Managing the technologies and technical stakeholders  to develop, manage, and deliver training.
• Overseeing training program interventions that include web-based seminars.

Building and maintaining credible relationships within the organisation.

• Build and maintains supportive relationships with all stakeholders.
• Building credibility with managers in the area in order to assist them in bridging gaps with existing and new employees.
• Training managers align with managers to identify training needs.
• Ensure that all stakeholders are kept abreast of progress and that communication sent internally and externally is professional

Value Creation in the business aligned to the needs and training or coaching requirements, which would change according to department requirements.

• Facilitate training sessions to external and internal stakeholders ensuring all new and existing sales representatives are competent in their Therapeutic areas.
• External Training: Facilitate professional and credible external trainings in accordance with commercial requests and needs.

Internal staff  

• Disease and Product /Selling skills
• Selling skills
• Soft Skills training according to the business need.
• The Training Manager would be required to upskill on multiple portfolios and to learn new skills according to business needs.
• New employees and existing employees will receive training, upskilling, and refresher training on:
• Working in-field with Sales Representatives to ensure that feedback and coaching is given regarding their portfolio/skills/knowledge.
• Constant support to the business as a mento and coach whether training on-the-job or during classroom training/ e-learning, workshops/ simulations etc…
• Assisting with launches in that NLP products pertaining to your portfolio must be facilitated to the relevant teams in collaboration with brand managers and regulatory.
• Modifies or creates course materials and training manuals to meet specific training needs.

Financial Objective

• Assisting the business to achieve their sales verse target by quality training interventions taking place.
• Manage training budget cost regarding meals, training meetings informal and formal.
• Ensure travel budget- flights and accommodation is in line with budget and policy.
• Manages costs for all training programmes in order to report to HOD regarding a return on investment

Administrative Functions and Reporting

• Bind all guides and manuals, Printing all training material relevant to the session.
• Ensure all assessments are compiled and relevant in time for training.
• Marking, feedback reports directed to HOD and reps.
• POE for CHIETA compiled with each learner
• Comply with all regulatory, compliance standards and align with compliance standards.
• Ensure deliverables are met timeously.
• Ensure up-to-date records of manuals and training sessions held are adhered to
• Review existing training materials produced by third parties to determine appropriateness and relevance.

Requirements

EDUCATION & EXPERIENCE

• Matric/ Grade 12
• Minimum of 3 years’ experience in the pharmaceutical industry
• Life Sciences diploma/degree
• Relevant applicable Facilitator/Training qualification an advantage- ODETDP qualification
• Disease Knowledge: CNS-, Hospital- Anesthesiology, psychiatry, neurology, hematology, female health experience an advantage
• Minimum 3 year Soft skills experience required
• Customer service, selling skills, EQ skills advantageous
• Computer literate – MS Office (MS Excel, MS PowerPoint)
• Drivers Licence and own transportation
• Ability to travel nationally when required
• Strong intercommunication written and verbal skills

SKILLS AND ATTRIBUTES

• Strong intercommunication written and verbal skills.
• Effective planning, organising and co-ordinating.
• Evaluate performance aligning to business needs
• Creative thinking and effective problem-solving
• Commercial and strategic awareness
• Independent, results-driven, and self-directed individual that can drive execution.
• Develop and deliver learning solutions that meet business needs
• Select and manage resources, including the employees, materials, and vendors, involved in developing and delivering learning initiatives
• Coach and instill a culture of confidence amongst Aspen’s Sales force

KNOWLEDGE

• Computer skills on MS Excel, PowerPoint, Word
• Ability to facilitate and assess medical sale representative qualification and its outcomes according to NQF Level 5 standards.
• In-depth pharmaceutical industry and disease product knowledge in order to facilitate sales and soft skills training on external and internal platforms.
• Technical ability to identify training needs, develop educational curricula and  present material effectively.
• Knowledge of compliance and marketing codes and policies.