Request for Tenders for the Provision of Pharmacovigilance Safety Database and Case Management System

The contract timeline includes the following:

Procurement Process Indicative Timeline:

• Issue RFT: 24/07/2026
• Closing date for queries: 11/09/2026 12 Noon
• Closing date for receipt of tenders: 25/09/2026 12 Noon

Contract Duration:

• The contract will run for three years, subject to satisfactory performance, and is extendable annually thereafter.

Tender Validity Period:

• A tender validity period of 12 months is required, starting from the closing date for receipt of tenders.

The contract start date and end date are not explicitly stated. Key milestones specific to the awarded contract's implementation (e.g., mobilization, go-live) are to be proposed by tenderers in their project plans rather than being fixed in the general contract timeline.

The core scope of work for this tender involves the provision of a Pharmacovigilance Safety Database and case Management System. The tenderer's proposed solution and implementation approach must clearly define all included products, services, activities, deliverables, integrations, and data services. Conversely, any items excluded from the proposed scope must also be explicitly identified.

The Statement of Work summary highlights the successful supplier's responsibilities, which include:

• Managing all deliverables and coordinating with HPRA project management from mobilisation through to project completion.
• Ensuring all supplier deliverables are completed on time, within budget, to the required quality standard, and within the agreed scope.
• Managing risks and monitoring performance throughout the project.
• Providing regular project status updates to the HPRA project manager.
• Planning and managing the supplier’s resources and any third parties involved in delivery, including coordinating with the HPRA project manager for timely access to required HPRA resources.
• Managing changes to project scope, deliverables, responsibilities, assumptions, dependencies, timelines, and costs.

Core deliverables mentioned include:

• Governance deliverables such as mobilisation materials, project plans, status reports, risk and issue logs, decision logs, action logs, and meeting records.
• Professional services covering roles such as Project Manager, Business Analyst, Analyst Programmer, Senior Analyst Programmer, Test Analyst, Test Manager, and Database Engineer/Administrator.
• Activities related to training, change management, and rollout, including preparing user groups, administrators, and support teams to use, manage, and support the solution effectively, as well as preparing for rollout, supporting cutover, confirming production/user/service readiness, and transitioning the solution into live operation and support.