PV Strategy & Process Design

PV Strategy, Process Design and Training

Efficient PV process setup is extremely important for Drug Safety departments of all pharmaceutical and biotech companies, regardless of their size. RxLogix team members have years of experience in business process setup for the entire safety value chain which includes Case Management, Aggregate Reporting, Signal Management and Risk Management.

Our experts have designed end to end business processes for the world’s top pharmaceutical companies and the smaller biotech companies as well. Our process design is based on best practices that are in the context of system capabilities as well as its limitations. This approach helps our clients not lose time and get the maximum returns from their new systems and the associated processes.

Do not stay awake at night, use RxLogix experience and the robustness of their process “know-how” to get the consistency of approach and assured outcomes.

Key Features

  • End to end business process design for:
    • Case Management
    • Aggregate Reporting
    • Signal Management
    • Risk Management
  • Business process design for the following scenarios:
    • New safety system or module implementation
    • Mergers and acquisitions
    • Integration of the Japan PV unit with the global PV harmonizing processes and integrating technology
    • Centralization or decentralization of certain PV functions
    • Commercialization of first clinical compound
    • Addition of new affiliates
  • Business and Operational IT SOPs development
  • Custom user manual/data handling manual development
  • Training materials development and delivery of training:
    • Administrator training
    • End-user training
    • Superuser training
    • Instructor-led training

Key Benefits

  • Best practices-based business processes delivering the highest possible productivity and compliance benefits after Go-live
  • Usage of automation and AI technologies to achieve maximum productivity gains
  • Processes setup in the context of RxLogix PV Suite making the business process design process efficient with minimum effort from the business resources
  • All levels of business process design i.e., L(0), L(1) and L(2)
  • Bringing practices used by other relevant size and type of companies
  • Faster and cost-effective implementation of new solutions