Establishing Pro-active and Real-time Pharmacovigilance Operations Oversight using Digitalization & Automation to Enhance Operational Efficiency, Quality and Regulatory Compliance
Pharmaceutical companies must submit a detailed safety management and risk management plan as part of their marketing authorization applications to regulatory bodies like the FDA, EMA, PMDA, and others. Post-approval, they are required to execute planned pharmacovigilance (PV) activities to ensure ongoing safety and compliance. While many life sciences companies outsource PV operations, they remain fully accountable. Manual oversight is often inefficient and error-prone, leading to compliance risks. As a result, there is a growing need for a digital, automated PV oversight framework to enhance efficiency, data quality, and real-time regulatory compliance.
Importance of PV Oversight
- Provides strategic direction and process guidance to enhance patient safety.
- Requires assessment of operational outcomes (People, Process, Technology, Productivity, etc.)
- Involves continuous identification of opportunities to enhance quality and compliance across PV
- Acts as a centralized governance process to facilitate stakeholder collaboration.
Majority of the Sponsors rely on spreadsheets, bespoke tools etc. to manage global PV operations currently.
Challenges of PV Oversight
Sponsor Perspective
Quality & Compliance OVERSIGHT
- Inflated self-reporting from vendor
- Existing tools/methods fragmented, complex and 1-2 months behind real-time
- Insufficient quality engagement / QMS
- Challenges obtaining earnest review and sharing of deviations and trend analyses
- Insufficient/ineffective training vendor staff.
Connected Process – Communication
- Roles & responsibilities - who, when, etc.
- Leadership versus accountability
- Process integration versus separation
- Time zones
- Expectations and assumptions
Alignment
- Alignment on Scope of Work and committed activities
- DSUR data provision
- DBL feature
- Case narratives format
- Identification of downgraded cases
- Change Orders
Service Provider Perspective
Quality & Compliance
- Compliance Adherence
- Audit Readiness
- Ongoing Quality Oversight
PV Thought Leadership
- Medical Knowledge
- Product Knowledge
People Management
- Process Training
- Skills Maturity
- Connected Collaboration
Delivery Efficiency
- Operational Efficiency & Oversight
- SLAs & Turn Around Times (TAT’s)
- Change management
Innovation Management
- Balancing R&D investments vs Profitability vs Growth
- Ongoing PV Regulatory updates
- AI/ Technology advancements
Digital Framework for PV Oversight
The PV Oversight framework comprises of logical functional components with purpose-built data capture forms, validated business rules engine, digital content management, integrated mailbox, audit trail, rules triggered alerts & notifications, user security management, safety report document templates, and configurations administration console to digitalize various pharmacovigilance operational activities and perform digital quality, risk and compliance oversight. Further, the PV Operations Oversight framework brings together all key operational and regulatory dimensions, including patient safety, SOPs, systems, day-to-day operations, and various stakeholders (internal teams, vendors, regulators, etc.). It further enables companies and service providers to proactively track critical insights and indicators such as quality, risk, compliance, and performance.
The framework further involves the usage of the system to digitalize various pharmacovigilance business process workflows, integration of existing database systems and define flexible business rules to proactively plan, execute and perform real-time digital quality, risk, and compliance governance.
Benefits of Digital Framework for PV Oversight
In summary, PV oversight acts as a strategic enabler for pharmaceutical companies by aligning safety practices with business goals, protecting patients, and sustaining trust with regulators and stakeholders.
Pharmacovigilance Automation & Agentic AI
As the volume and complexity of safety data grow exponentially, traditional manual pharmacovigilance processes struggle to keep pace with global regulatory expectations. Automation and AI are increasingly essential to streamline case processing, improve accuracy, and reduce compliance risk.
Key Benefits:
- Faster Case Processing: Automation significantly reduces turnaround time for case intake, triage, data entry, and follow-ups.
- Improved Data Accuracy: AI-driven validation and duplicate detection reduce human error and ensure consistent data quality.
- Scalable Operations: Automation allows PV teams to handle higher case volumes without proportional headcount increases.
- Enhanced Signal Detection: AI/ML algorithms can identify safety signals earlier and more accurately from diverse data sources.
- Cost Efficiency: Reduces operational overhead and avoids penalties from delayed or inaccurate reporting.
- Regulatory Readiness: Enables real-time tracking, audit trails, and consistent documentation aligned with global compliance standards.
- Focus on High-Value Work: Frees up PV professionals to focus on analysis, risk assessment, and strategic oversight rather than repetitive tasks.
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