Compliance and Pharmacovigilance Pharmacist (Fixed-Term)

KEY RESPONSIBILITIES

Strategy and Development

• Contribute to the creation and implementation of best practices processes and procedures to aid and improve operational performance and timeous availability of product to market.
• Contribute to new business initiatives and projects.

Operational activities:

• Coordinate the compilation of artwork packs in line with internal procedures and legal requirements.
• Implement PPM codes, barcodes and CCP’s (initiated by Regulatory Department), where necessary in line with departmental policies and procedures
• Liaise with Supply, Regulatory Affairs, Marketing and Design department to ensure operational and legal requirements are met.
• Liaise with external stakeholders and suppliers, including printers and packers, to ensure artwork projects are delivered on time.
• Proactively plan implementation and availability of printer proofs at supplier/printers
• Liaise with managers and Heads of department to ensure launch plans are met.
• Assist with the implementation and coordination of departmental operational activities to ensure timeous launch of new and existing brands.
• Monitor non-conformances and provide a progress report monthly to Head of Department on artwork/project status.
• Review artwork components in line with legal requirements and business needs as per agreed timelines.
• Assist with preparation of Pharmacovigilance inspections.
• Coordinate and manage the alignment of artwork and safety updates for the export market.
• Drive the implementation of safety information for the South African market.
• Assist with the approval of advertising and promotional material.
• Assist in managing and maintaining Pharmacovigilance systems in line with SAHPRA guidelines and as a member of the Pharmacovigilance team and Committee.

Good Manufacturing practice (GMP)

• Maintain all GMP principles in line with departmental quality system and SAHPRA requirements.
• Maintain Marketing Code principles.

Documentation & Systems ManagementDocumentation

• Manages the compilation and tracking of Compliance, Pharmacovigilance, Regulatory and Quality activities.
• Manages adherence to SOP’s and departmental deadlines.
• Assist with Launch checklists.
• Compiles monthly status reports.

Systems

• Drive accuracy and efficiency of the departmental eDMS.
• Ensure ongoing compliance with SAHPRA requirements.

PRE-REQUISITES

• B. Pharm registered with the SA Pharmacy Council
• Minimum of 2 – 3 years Regulatory hands-on experience, within the pharmaceutical industry.
• Able to perform all standard registration processes under specialist guidance.
• Fluency in Afrikaans (speaking, reading, and writing) preferred