Pharmacovigilance Services
I provide expert pharmacovigilance services to ensure drug safety. My focus is on monitoring, assessing, and mitigating risks associated with pharmaceutical products, ensuring compliance with regulatory requirements.
Regulatory Compliance
With extensive knowledge in regulatory frameworks, I ensure that all safety processes align with industry standards. I guide organizations in navigating compliance challenges and adapting to evolving regulations.
Automation Solutions
I specialize in implementing automation solutions that streamline safety reporting processes. By leveraging technology, I enhance efficiency while maintaining accuracy and compliance in pharmacovigilance.
Project Management
I offer project management services tailored to the pharmaceutical industry. My expertise ensures that safety projects are executed on time, within budget, and in adherence to regulatory timelines.
Professional Summary
I am a seasoned pharmacovigilance expert and project manager with a strong track record in compliance, efficiency and team leadership. I possess deep expertise in regulatory affairs, AI-driven automation, and global case processing, successfully managing transitions, audits, and process optimizations across various pharmaceutical portfolios.
Key Strengths
Certifications
Education:
Syneos Health, Bangalore
2023- 2024, Manager Pharmacovigilance & safety
IQVIA RDS India Pvt Ltd
2019 – 2023, Associate Manager, Safety Operations
Bioclinica India Pvt Ltd
2013 – 2019, Assistant Project Manager & Various other roles
- iRxSafe development
- Automating Pharmacovigilance Case Processing
- Pharmacovigilance Transition Project
- Streamlining ICSR Case Allocation System
- Pharmacovigilance Safety Database Migration
Project Overview
| Objective | Solution | Role |
| Streamline case processing with AI-powered intake solution | iRxSafe Implementation | Project Lead & Implementation Director |
Key Achievements
Zero downtime during implementation 100% compliance with PV reporting standards Significant reduction in manual processing time Enhanced data accuracy across case intake High user satisfaction and adoption rates
Implementation Approach
Implementation Phases
| Phase | Key Activities | Deliverables |
 Discovery | Gap analysis, requirement gathering | System specifications, project charter |
 Development | System customization, API integration | Tailored iRxSafe solution, integration plan |
 Testing | UAT, validation testing | Validation reports, issue resolution |
 Documentation | SOP creation, training materials | Comprehensive SOPs, training modules |
 Deployment | Phased rollout, user training | Fully operational system, trained users |
 Optimization | Performance monitoring, feedback collection | Enhancement roadmap, KPI dashboard |
System Integration Framework
Risk Mitigation Strategy
| Risk Area | Mitigation Approach | Monitoring Method |
 Data Security | Implement encryption, access controls, GDPR compliance | Security audits, penetration testing |
 User Adoption | Early stakeholder engagement, targeted training | User feedback surveys, usage metrics |
| System Compatibility | Comprehensive API mapping, interface testing | Integration validation, error tracking |
 Business Continuity | Parallel systems during transition, fallback procedures | Performance monitoring, incident reports |
| Data Quality | Validation rules, data cleaning procedures | Quality metrics, error rate tracking |
Performance Improvements
| Metric | Before | After | Improvement |
| Case Processing Time | 45 min/case | 15 min/case | 67% reduction |
| Data Entry Errors | 8% | <1% | 88% reduction |
| Regulatory Compliance | 97% | 100% | 3% improvement |
| User Satisfaction | 65% | 92% | 27% improvement |
Key Innovations
- AI-powered data extraction from unstructured sources
- Automated coding of adverse events using MedDRA terminology
- Predictive analytics for case prioritization
- Real-time compliance checking against regulatory requirements
- Intelligent workflow routing based on case complexity
Business Impact
- Operational: Streamlined case intake with reduced manual intervention
- Quality: Enhanced data accuracy and consistency
- Compliance: Improved regulatory reporting timeliness
- Strategic: Data-driven insights for safety signal detection
- Financial: Reduced resource requirements for routine case processing
Enhancing Operational Efficiency with Power Automate & SharePoint
Project Overview
| Objective | Technology | Role |
| Streamline PV processes through automation | Power Automate & SharePoint | End-to-End Project Manager |
Key Achievements
40% increase in case processing efficiency Significant reduction in manual interventions Measurable cost efficiency gains Successfully integrated automation with compliance requirements Created reusable automation framework for future projects
Project Lifecycle
Team Structure & Collaboration
Project Phases & Deliverables
| Phase | Key Activities | Deliverables |
| Discovery | Needs assessment, stakeholder interviews | Requirements document, cost estimates |
 Planning | Resource allocation, timeline development | Detailed project plan, risk matrix |
| Design | Process mapping, workflow optimization | Automation architecture, workflow diagrams |
 Development | Power Automate configuration, SharePoint setup | Functional automation workflows |
| Testing | UAT, validation, compliance verification | Test cases, validation reports |
| Deployment | Phased rollout, training, support | Fully operational system, training materials |
| Evaluation | Performance monitoring, ROI assessment | Post-implementation report, KPI dashboard |
Risk Management Framework
| Risk Category | Mitigation Strategy | Contingency Plan |
 Technical Failures | Thorough testing, staged implementation | Manual fallback procedures |
| User Adoption | Inclusive design process, targeted training | Champions program, additional support |
| Data Integrity | Validation checks, audit trails | Reconciliation procedures |
| Timeline Slippage | Buffer periods, critical path monitoring | Resource reallocation plan |
| Compliance Gaps | Regulatory consultant involvement | Pre-submission reviews |
Efficiency Improvements
| Process Area | Before Automation | After Automation | Improvement |
| Document Processing | 25 min/case | 8 min/case | 68% reduction |
| Case Triage | 15 min/case | 5 min/case | 67% reduction |
| Follow-up Management | Manual tracking | Automated alerts | 90% reduction in missed deadlines |
| Compliance Reporting | 4 hours/week | 1 hour/week | 75% time savings |
| Overall Efficiency | Baseline | 40% increase | Significant ROI |
Change Management Approach
- Communication Strategy: Regular updates via team meetings, newsletters, and dedicated Slack channel
- Training Approach: Role-based training sessions, self-paced tutorials, and reference materials
- Feedback Mechanism: Structured surveys, open forums, and direct observations
- Continuous Improvement: JIRA-based change request system with stakeholder approval workflow
Business Impact
- Operational: Faster case processing with fewer errors
- Financial: Reduced resource requirements with quantifiable cost savings
- Compliance: Enhanced tracking and documentation of regulatory activities
- Strategic: Reallocation of specialized staff to high-value activities
- Cultural: Shift toward data-driven process optimization
Project Overview
| Objective | Timeline | Role |
| Transition pharmacovigilance operations from external vendor to internal teams | Completed in 90 days | Project Lead & PV Operations manager |
Key Achievements
100% business continuity maintained during transition Zero compliance issues or regulatory findings Established complete local & global PV teams Reduced costs while increasing process control Created reusable transition playbook adopted across organization
The Transition Process
Team Structure
Strategic Approach
| Challenge | Solution | Result |
 Complex Regulatory Environment | Established compliance-first framework with region-specific protocols | Met all global standards (EMA, FDA, PMDA) |
| Tight Transition Timeline | Implemented parallel processing with vendor | Maintained all KPIs throughout transition |
 Knowledge Gap Risk | Structured knowledge transfer & training program | Seamless continuity of operations |
| Staffing Across Regions | Partnered with HR on targeted recruitment | Built fully staffed teams within timeline |
Implementation Tools
- Project Tracking: JIRA dashboards & Excel trackers
- Quality Assurance: Monthly audits & real-time case monitoring
- Process Management: Custom SOPs & Work Instructions
- Training: Role-specific modules & shadowing protocols
- Governance: Centralized oversight with regular stakeholder updates
Business Impact
- Financial: Reduced vendor costs with improved operational control
- Regulatory: Enhanced compliance positioning for inspections
- Operational: Increased process visibility and accountability
- Organizational: Created scalable PV function aligned with company growth
Lessons Learned
Early stakeholder engagement and a compliance-first mindset were critical success factors in this transition. Building redundancies into the timeline provided necessary flexibility when challenges arose.
Objective: Migrate to a new pharmacovigilance database with minimal operational disruptions while ensuring compliance.
Role: Led the project from planning to execution, overseeing database migration, and integration with existing systems.
People: To handle the database migration, I assembled a project team comprising database administrators, IT support, pharmacovigilance officers, and compliance specialists. I facilitated cross-training to ensure team members were proficient in the new database functionalities and prepared for any technical challenges. I engaged the regulatory compliance team early on to ensure data integrity during the migration. Key stakeholders, including departmental heads and compliance officers, participated in regular status updates, ensuring that the project remained on track and that any concerns were promptly addressed.
Process: In the planning phase, I conducted a thorough risk assessment to anticipate potential disruptions and defined mitigation strategies. A phased migration schedule was established, with checkpoints for data validation, quality assurance, and regulatory review. This structured approach minimized data loss risks and maintained operational continuity. Using historical data, I created cost estimates and obtained budget approvals. Each phase was tracked using JIRA, enabling real-time updates and accountability. The project plan included specific milestones such as data mapping, transfer, validation, and compliance checks. To manage changes, a robust change control process was implemented, capturing any adjustments needed due to technical challenges or regulatory updates. Regular quality audits were conducted to confirm accuracy, and upon completion, a post-migration review session was held to document lessons learned and share best practices with other departments.
Business Environment: Addressed challenges through a structured change management plan, using JIRA for tracking issues and updates. Implemented contingency plans to handle disruptions and conducted regular quality audits.
Outcomes: The database migration was completed successfully, achieving compliance and exceeding KPIs without any regulatory escalations.
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