Objectives

The primary objective of this tender is to procure a comprehensive Pharmacovigilance Digitization Solution that includes maintenance and support for a period of 36 months, with an option to renew for an additional 24 months. The solution aims to modernize SAHPRA's core business processes related to the regulation, monitoring, and safety assessment of health products, particularly focusing on establishing a Pharmacovigilance platform as part of the Regulatory Information Management Ecosystem (RIMeS). The goal is to automate and digitize core activities such as adverse event reporting, case management, signal detection, and regulatory compliance, thereby improving operational efficiency, reducing backlogs, and ensuring international standards are met.

Scope

The scope encompasses the provision of a Pharmacovigilance platform integrated within the broader RIMeS project, including:

• Development and deployment of a customizable, integrated pharmacovigilance database and system.
• Implementation of modules for data collection, case management, AI-assisted coding, signal detection, aggregate reporting, and dashboards.
• Support for multiple data sources such as healthcare professionals, clinical trials, literature, and regulatory reports.
• Integration with external systems and standards (e.g., E2B R3, MedDRA, WHO Drug Dictionary, VEDDRA, IMDRF).
• Support for regional decentralization, multi-language capabilities, and compliance with international and local regulatory requirements.
• Provision of maintenance, support, and training over the contract period.

Technical Requirements

The technical specifications include:

• Structured electronic forms for Individual Case Safety Reports (ICSR) aligned with ICH E2B(R3) standards.
• End-to-end case management with automated triage, data validation, duplicate detection, and lifecycle tracking.
• AI-powered functionalities for case coding (MedDRA, WHO Drug Dictionary), narrative generation (NLP), trend analysis, and causality assessment.
• Comprehensive product and event dictionaries with management features, including integration with external terminologies.
• Advanced signal detection algorithms (ROR, PRR, EBGM, Bayesian models, etc.) with visualization tools.
• Configurable dashboards and reporting tools supporting regulatory and operational needs.
• Interoperability via APIs, XML data exchange, and integration with systems such as VigiFlow, NDOH, AMA, and WHO databases.
• Cloud hosting compliant with POPIA, GDPR, HIPAA, and security standards including RBAC, audit trails, and electronic signatures.
• Usability features including multi-language support, responsive design, notifications, and training modules.
• Modular architecture supporting phased deployment, scalability, and future enhancements.

Skills Requirements

The tender specifies the need for a multidisciplinary team with expertise in:

• Pharmacovigilance Subject Matter Experts: Knowledge of safety monitoring, regulatory requirements, and software tools.
• Business Analysts: Experience in business process analysis, requirements elicitation, and translating needs into technical specifications.
• UX/UI Designers: Skills in user research, wireframing, prototyping, and ensuring user-friendly interfaces.
• Front-end Developers: Proficiency in HTML, CSS, JavaScript, and responsive design.
• Back-end Developers: Experience with database design, server-side programming, API integration, and security.
• AI/ML Developers: Expertise in natural language processing, data modeling, auto-coding, and trend analysis.
• Data Scientists: Skills in data analysis, pattern recognition, and biostatistics for signal detection.
• Project Managers: Proven experience in managing complex IT projects, timelines, and stakeholder communication.

Additionally, the team should be capable of providing training, support, and documentation to ensure effective system adoption and ongoing maintenance.