Bianca Van Niekerk

Financial Management:

• Ensure effective utilization of resources to maintain cost-effective processes within Regulatory Affairs (RA) department.
• Adhere to RA department budget and forecasts to manage expenses and allocations efficiently.

Promotional Material Review:

• Review and approve promotional materials related to medicines and related products for South Africa (SA) and Southern African Development Community (SADC) markets.
• Ensure compliance with applicable legislation, codes of practice, regulations, guidelines, and corporate requirements.
• Liaise with marketing divisions to provide regulatory advice, address queries, and manage timelines for promotional campaigns.
• Assist in reviewing product information relevant to each promotional campaign.
• Attend promotional campaign concept presentations to provide regulatory support and input as needed.

Printed Packaging/Artwork Approval:

• Review and approve concepts for new or updated artwork and printed packaging materials for medicines and related products in compliance with SA legislation and corporate standards.

Afrikaans Translation of PI and PILs:

• Assist in translation and/or validation of Afrikaans Professional Information (PI) and Patient Information Leaflets (PILs) for both new and existing products.
• Ensure translations are accurate and completed within specified timelines.

Project Management and Operational Support:

• Provide assistance with specific projects and operational support for RA Compliance team.
• Assist in uploading, creating, and approving Change Controls, Standard Operating Procedures (SOPs), Work Instructions, Standard Forms, Deviations, etc., on quality management system.

General Responsibilities:

• Ensure systems and procedures align with RA Quality Management System (QMS) and maintain compliance with relevant Standard Operating Procedures (SOPs).
• Meet agreed Key Performance Indicators (KPIs) related to regulatory compliance and departmental goals.
• Support continuous development and improvement of RA Compliance function, aligned with company core values.
• Maintain records as per Pharmacare requirements and ensure adherence to company Health & Safety procedures.
• Participate in training programs to enhance regulatory knowledge and skills.

Additional Considerations

• Compliance and Quality Assurance: Ensure all activities adhere to regulatory requirements and maintain high standards of compliance.
• Communication and Collaboration: Work closely with cross-functional teams including Regulatory Affairs, Marketing, Quality Assurance, and others to achieve regulatory objectives.
• Professional Development: Stay updated with regulatory changes, industry trends, and best practices through continuous learning and participation in professional development opportunities.

Prescription Management:

• Evaluate, prepare, and dispense both chronic and acute prescriptions accurately and efficiently.
• Ensure compliance with legal and regulatory requirements for prescription medications.

Schedule 6 Medication Management:

• Responsible for handling and management of Schedule 6 medications (prescription-only medications).

Inventory Management:

• Manage stock levels by re-ordering medications and conducting cycle counts and stock takes to ensure adequate inventory levels.

Customer Service:

• Handle customer complaints effectively and ensure high levels of client satisfaction.
• Provide counseling and advice to customers on medication usage, potential side effects, and interactions.

Supervision and Training:

• Oversee duties of pharmacist assistants and pharmacy students.
• Provide mentorship and guidance on pharmacy procedures and best practices.

Additional Responsibilities

• Compliance and Safety: Ensure compliance with pharmacy regulations and maintain a safe environment for dispensing medications.
• Patient Education: Educate patients on proper medication usage, including dosage instructions and potential side effects.
• Health Promotion: Promote health awareness through campaigns and initiatives within the community.
• Quality Assurance: Implement quality assurance measures to maintain accuracy in dispensing and patient safety.

Regulatory Authority Submissions:

• Prepare and compile submission documentation for regulatory authorities. This includes applications, amendments, variations, renewals, and other regulatory submissions required for drug approvals or updates.

Documentation Accuracy:

• Ensure all submission documentation is accurate, complete, and meets regulatory requirements. This involves thorough review and verification of data, formats, and content.

Filing and Electronic Document Management:

• Maintain accurate physical and electronic filing systems for submission documentation. This includes proper organization, labeling, and storage of documents to facilitate easy retrieval and compliance with document retention policies.

Document Control:

• Manage document control processes to ensure accurate tracking and maintenance of submission documents. This may involve using documentation trackers or databases to monitor the status and updates of submissions.

Package Insert Management:

• Maintain accurate documentation trackers specifically for the Package Insert (PI) folder. This involves tracking versions, updates, and ensuring that all changes are properly documented and communicated.

Additional Responsibilities

• Compliance Monitoring: Monitor regulatory requirements and guidelines to ensure ongoing compliance with local and international regulatory standards.
• Communication and Collaboration: Liaise with internal teams (e.g., clinical, quality, manufacturing) and external partners (e.g., regulatory agencies, consultants) to gather necessary information and ensure timely submission of regulatory documents.
• Quality Assurance: Implement quality control measures to ensure accuracy and consistency in regulatory submissions and documentation.
• Training and Development: Stay updated with regulatory changes and participate in training programs to enhance regulatory knowledge and skills.

• Evaluation, preparing and dispensing of medication to patients as well as wards within hospital environment.
• Interacting with other health professionals in delivering quality healthcare services.
• Contact prescriber's when required to promote optimal dosing intervals etc.
• Supervision of pharmacist assistants.
• Patient counseling and advising on medication usage.
• Assist in ward stock replenishment and of intra-group sales, scheduled drugs to units.

Prescription Management:

• Evaluate, prepare, and dispense both chronic and acute prescriptions accurately and efficiently.
• Ensure compliance with legal and regulatory requirements for prescription medications.

Schedule 6 Medication Management:

• Responsible for handling and management of Schedule 6 medications (prescription-only medications).

Staff Management:

• Manage dispensary staff, including oversight of overtime and leave schedules to maintain operational efficiency.

Inventory Management:

• Manage stock levels by re-ordering medications and conducting cycle counts and stock takes to ensure adequate inventory levels.

Customer Service:

• Handle customer complaints effectively and ensure high levels of client satisfaction.
• Provide counseling and advice to customers on medication usage, potential side effects, and interactions.

Supervision and Training:

• Oversee duties of pharmacist assistants and pharmacy students.
• Provide mentorship and guidance on pharmacy procedures and best practices.

Additional Responsibilities

• Compliance and Safety: Ensure compliance with pharmacy regulations and maintain a safe environment for dispensing medications.
• Patient Education: Educate patients on proper medication usage, including dosage instructions and potential side effects.
• Health Promotion: Promote health awareness through campaigns and initiatives within the community.
• Quality Assurance: Implement quality assurance measures to maintain accuracy in dispensing and patient safety.

Collaboration and Communication:

• Interact with healthcare professionals to deliver high-quality healthcare services.
• Contact prescribers to discuss and optimize medication regimens.

Supervision and Training:

• Oversee, mentor, and train pharmacist interns and assistants.
• Provide guidance on pharmacy-related issues and assist units with training needs.

Patient Care:

• Counsel patients on medication usage and potential side effects.
• Provide advice on medication adherence and management of prescriptions.

Inventory Management:

• Assist in ward stock replenishment, including high-risk and scheduled drugs.
• Conduct stock take and cyclical stock counts to maintain inventory accuracy.

Specialized Tasks:

• Manage Section 21 applications for in-hospital medication use.
• Order and handle Total Parenteral Nutrition (TPN) products.

On-call Responsibilities:

• Participate in on-call duty for one week per month to address urgent pharmacy needs.

Quality Assurance:

Perform quality ward rounds to ensure medication safety and adherence to protocols.

Professional Development:

Stay updated with new medications, guidelines, and industry trends.

Patient Safety:

Prioritize patient safety through accurate medication dispensing and monitoring.

Prescription Management:

• Evaluate, prepare, and dispense both chronic and acute prescriptions accurately and efficiently.
• Ensure compliance with legal and regulatory requirements for prescription medications.

Schedule 6 Medication Management:

• Responsible for handling and management of Schedule 6 medications (prescription-only medications).

Inventory Management:

• Manage stock levels by re-ordering medications and conducting cycle counts and stock takes to ensure adequate inventory levels.

Customer Service:

• Handle customer complaints effectively and ensure high levels of client satisfaction.
• Provide counseling and advice to customers on medication usage, potential side effects, and interactions.
• Coordinated with insurance companies to resolve billing disputes, ensuring timely reimbursement for pharmacy services rendered.

Supervision and Training:

• Oversee duties of pharmacist assistants.

Additional Responsibilities

• Compliance and Safety: Ensure compliance with pharmacy regulations and maintain a safe environment for dispensing medications.
• Patient Education: Educate patients on proper medication usage, including dosage instructions and potential side effects.
• Health Promotion: Promote health awareness through campaigns and initiatives within the community.
• Quality Assurance: Implement quality assurance measures to maintain accuracy in dispensing and patient safety.