Our technology-enabled safety support includes advanced compliance, safety data reporting and analytics.

Enabling Leaders to Leverage Pharmacovigilance Technology to Drive Successful Outcomes

Technology plays a huge role in pharmacovigilance — both before and after a drug is released to the market. Key stakeholders of the Life Sciences industry such as patients, physicians, providers and payers are demanding safer drugs and faster responses to safety concerns from biopharmaceutical companies. Divergent regulatory requirements, an ever-increasing volume of data from traditional as well as new age sources, and the need to mine large data sets are all challenges biopharmaceutical companies face in the imperative to ensure patient safety and effectively manage unintended drug effects.

Challenges faced by Pharmacovigilance Leaders

Patient Safety

Regulatory Compliance

Cost Effectiveness

Pharmacovigilance leaders are charged with ensuring patient safety, staying compliant, and achieving more with existing resources. Having the right technology infrastructure is integral to achieving this mandate. Some of the other common challenges these leaders face include:
  • Automation of case processing as well as other routine pharmacovigilance activities and the potential use of Artificial Intelligence and Natural Language Processing tools to streamline processes
  • Expanding the usage of existing system capabilities through upgrades or potentially employing new solutions to bridge gaps to be scalable to conform with the changing nature of the organization’s product portfolio and growth aspirations
  • Utilizing data analysis and visualization tools to process large availability of data volume in shorter timeframes and with improved, meaningful outcomes for patients, providers and health authorities
  • Tracking systems tools to measure compliance and ensure oversight of the performance of the global (affiliate) network
  • Secure and economic data storage solutions to ensuring large volumes of data is stored and maintained as required by local regulations in a feasible and cost-efficient manner
  • Maintenance of systems in-house verses outsource to a specialized vendor
  • Determining the right hosting solution – on premise, the cloud or private cloud
  • Ensuring adherence to data privacy requirements

As a leading PV consulting organization, Navitas Life Sciences benefits from latest insights in the PV technology space derived from benchmarks and discussions at our industry network pvtech®, comprising of over 25 large and mid-size Life Sciences organizations. For more information on pvtech®– please click here

Navitas Life Sciences Enables Successful Outcomes through PV Technology Services and Solutions

PV technology assessment and roadmap development

Affiliate compliance, oversight and dashboarding tools

Automating the generation of PSMF annexes

System integration support


safetyREADY®, an accelerated solution for implementation, upgrade and migration for Oracle’s Argus Safety suite

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