Pharmacovigilance Automation
Leveraging data-centric emerging technologies
to achieve greater efficiency
OUR TEAM OF EXPERIENCED PROFESSIONALS CAN SUPPORT YOUR PV AUTOMATION NEEDS
The environment in which life sciences companies are operating is changing at an alarmingly fast rate. With lower investments to bring out new drugs and a shorter time to market them, we are witnessing a response of maturing IT systems, digital trends, and drivers that are shaping the future and creating opportunities to further transform PV. This doesn’t come without its challenges with both validation and capacity remaining something of a barrier, coupled with unclear expectations from regulators. At Navitas Life Sciences, we have the required skillset and experience to leverage data-centric merging technologies that support your PV automation requirements, using a combination of internal and external tools we can help you to achieve a full automation experience, realizing greater efficiencies and ensuring proactive PV.

ICSR is the main focus of
PV Automation
According to the 2020 benchmark reports from our industry leading networks, pvnet® and pvconnect®, ICSR remains the main area of focus for PV Automation with some 86% of large and 48% of Small-Medium companies automating the process.
According to the reports, other areas of interest for automation include:
- Aggregate Reporting
- Signal Management
- Risk Management
HOW NAVITAS LIFE SCIENCES CAN SUPPORT YOUR PV AUTOMATION INITIATIVE


Learn how we successfully leveraged automation for expedited end-to-end ICSR processing and submissions
Our PV Automation services include

PV Automation Strategy
We can build a PV Automation Strategy to support a digitalized future
- Exploring industry trends
- Identifying automation opportunities
- Defining a high level solution(s) to include data sources, process steps, and tools
- Developing a plan for implementation to include:
- A business case
- Realization of TOI
- A change management approach

Technology Implementation and Change Management
We can implement leading edge technology reinforced with Change Management plans
- Developing data transformation routines
- Building and extracting ML data
- Reconfiguring the Safety Database to enable process automation
- Validation – to include dry-runs and pilots
- Managing change, Standard Operating Procedures (SOPs), and Web Intelligence
- Training support

Support and Maintenance
We provide ongoing Support and Maintenance
- Supporting users to address issues and queries
- Supporting vendor management
- Monitoring the application
- Planning for additional MLcycles and/or verifications
- Planning for changes and/or upgrades
ADVANTAGE OF OUTSOURCING YOUR PV AUTOMATION REQUIREMENTS TO NAVITAS LIFE SCIENCES

Invest in Key Capabilities
- Digital technology
- Data and analytics
- Source and upskill talent

Foster the Right Culture
- Innovation
- Agility
- Data centricity

Forge Partnerships
- Internally across the enterprise
- Industry: Vendors, Regulators, and Academia
- Influence with mutual benefit

Demonstrate Value
- Start small and build
- Deliver ROI
- Sustain the gains