Prakkriti Verma - Pharmacovigilance Operations Expert
Associate Manager with 10+ years of experience driving excellence in global pharmacovigilance operations, regulatory compliance, and team leadership.
Professional Summary
PV Operations Expert
Project Management Professional and registered Pharmacist with 10 years in global pharmacovigilance operations, managing 1200+ ICSRs monthly with FDA/EMA/ICH compliance.
Process Innovator
Automated ICSR workflows achieving 60% efficiency gain and trained 27+ team members in MedDRA coding, QC, and client-ready deliverables.
Client Liaison
Primary PV liaison for EU/US clients, ensuring seamless collaboration and strict compliance with pharmacovigilance requirements.
Future Outlook
Embracing AI & Automation
I aim to integrate cutting-edge AI and automation to revolutionize drug safety monitoring, enhancing efficiency and predictive capabilities in pharmacovigilance.
Global Compliance Leadership
My goal is to further strengthen global regulatory compliance frameworks, navigating complex international guidelines to ensure robust patient safety standards.
Fostering Team Innovation
I aspire to lead and mentor high-performing pharmacovigilance teams, cultivating a culture of continuous learning and proactive problem-solving.
Industry Insights
Staying at the forefront of pharmacovigilance requires a deep understanding of evolving trends and challenges that shape drug safety and patient outcomes globally. Continuous adaptation and innovation are crucial to navigate the complexities of drug development and post-market surveillance.
AI & Machine Learning
Harnessing artificial intelligence and machine learning is revolutionizing adverse event detection, signal management, and risk assessment for enhanced drug safety monitoring. This includes predictive analytics and automated case processing.
Real-World Evidence
Integrating real-world data sources (RWD) like electronic health records, patient registries, and social media provides crucial insights into drug safety profiles in diverse populations and under routine clinical conditions.
Global Regulatory Harmonization
Navigating the complex landscape of international regulations demands continuous adaptation and a proactive approach to ensure compliance across diverse markets, aiming for consistent global safety standards.
Patient-Centric Approaches
The shift towards patient-centric pharmacovigilance emphasizes collecting and integrating patient-reported outcomes (PROs) and direct patient engagement to capture a more holistic view of drug safety experiences.
Advanced Data Analytics
Leveraging sophisticated data analytics tools and techniques allows for deeper insights from vast datasets, identifying subtle patterns and trends in adverse event reporting that traditional methods might miss.
Personalized Medicine & PV
As therapies become increasingly personalized, pharmacovigilance must adapt to assess safety profiles for smaller, more targeted patient populations, often requiring innovative monitoring strategies.
Core Expertise
Leadership & People Management
Team leadership, mentoring, delegation, coaching, recruitment, performance management, and skill-gap analysis.
Pharmacovigilance Expertise
End-to-end ICSR processing, SAE reporting, signal detection, risk management, MedDRA coding, and WHO-DD compliance.
Regulatory & Compliance
FDA/EMA/ICH-GCP compliance, EU MDR, 21 CFR Part 11 & 4, audit readiness, and PSMF maintenance.
Project Management & Strategy
Strategic planning, project execution, resource allocation, timeline management, and stakeholder communication for PV initiatives.
Data Management & Analytics
Data collection, quality assurance, trend analysis, metrics reporting, and utilization of PV databases for insights.
Cross-functional Collaboration
Effective collaboration with clinical, regulatory affairs, quality assurance, and IT teams to achieve organizational goals.
Technical Proficiency
Database Systems
- Argus (v8.1+)
- AWARE
- AEGIS
- Veeva Safety
- ROAM Analytics
Research Tools
- MedDRA (v25+)
- WHO-DD
- AI-powered language processing
Career Highlights at Parexel (2022-2023)
30%
ICSR Accuracy Boost
Achieved a remarkable 30% boost in Individual Case Safety Report (ICSR) accuracy by spearheading the integration of an innovative AI-powered language processing tool. This transformative initiative automated the laborious listedness assessments across more than 50 complex drug labels, significantly reducing manual review time. The enhanced accuracy directly contributed to more reliable safety data, strengthening our compliance posture with global pharmacovigilance regulations like those from FDA and EMA.
15%
YoY Productivity
Drove a substantial 15% year-over-year productivity increase within the pharmacovigilance operations team. This was accomplished by implementing a comprehensive mentorship program, personally guiding and developing 27 team members through structured training and hands-on project involvement. A testament to the program's success, 8 team members earned promotions, and we maintained zero attrition during several critical, high-pressure projects, ensuring continuity and expert delivery.
35%
QC Error Reduction
Reduced Quality Control (QC) errors by 35% within just four months through the strategic implementation of biweekly skill-gap analysis sessions. These sessions were complemented by targeted, constructive feedback sessions that addressed specific areas for improvement in data entry, coding, and case processing. This systematic approach not only minimized rework and improved data integrity but also fostered a culture of continuous learning and excellence within the team, leading to more robust safety data for clients.
Operational Excellence
Process Automation
Streamlined ICSR processes to minimize manual intervention within 6 months.
Quality Improvement
Revamped QC checklists and governance frameworks, reducing vendor-related discrepancies.
Productivity Boost
Implemented real-time task tracking and skills-based delegation, maintaining 99.8% compliance across 1,200+ monthly ICSRs.
Reduced ICSR errors by developing 10+ standardized templates/SOPs adopted globally, saving 200+ hours/month in rework.
Previous Experience (2015-2022)
Pharmacovigilance Specialist
- Consistently achieved 100% on-time submission for over 500 serious adverse events (SAEs) annually across diverse therapeutic areas, ensuring strict adherence to global regulatory deadlines (e.g., 7-day, 15-day reporting requirements) for both expedited and periodic reports to regulatory bodies like the FDA and EMA.
- Spearheaded initiatives that slashed regulatory report turnaround time by 40% through implementing a new automated reporting tool and optimizing workflow between data entry and medical review, significantly accelerating the submission of critical safety information for new drug applications.
- Slashed data entry errors by 35% within 6 months by overhauling Quality Control (QC) protocols, introducing double-blind review processes, and providing targeted training on MedDRA and WHO-DD coding, thereby enhancing overall data quality and integrity for risk assessments.
- Actively participated in signal detection and risk management activities, contributing to the development of aggregate reports (e.g., PSURs, DSURs) and assisting in the identification of potential safety signals for investigational and marketed products.
- Managed and maintained pharmacovigilance databases, ensuring data integrity, accurate data entry, and adherence to company SOPs and global regulatory guidelines for robust data analysis and reporting.
- Provided expert guidance and support to clinical teams on PV-related queries, fostering a strong collaboration to ensure comprehensive safety data collection throughout clinical trial phases.
Team Leadership
- Successfully led a dynamic 12-member team responsible for processing over 2,000 Individual Case Safety Reports (ICSRs) during the peak of critical COVID-19 vaccine and therapeutic trials, maintaining high data accuracy under intense pressure.
- Achieved an outstanding 99.9% audit-ready case rate with strict 48-hour processing targets for high-priority cases by implementing rigorous internal checks and cross-functional collaboration strategies.
- Maintained an impeccable record of zero critical findings across 5 consecutive FDA and EMA pharmacovigilance audits, demonstrating robust compliance and operational excellence in complex global regulatory environments.
- Implemented a comprehensive training and onboarding program for new team members, significantly reducing ramp-up time by 25% and ensuring rapid integration into complex pharmacovigilance workflows.
- Fostered a high-performance culture by establishing clear KPIs and conducting regular performance reviews, leading to a 10% improvement in team efficiency and a 15% increase in employee engagement.
- Served as a primary point of contact for inter-departmental collaboration, successfully resolving complex case processing issues and streamlining communication channels between PV, medical affairs, and regulatory teams.
Early Career at Quantum Solutions (2012-2015)
ICSR Management
Orchestrated over 5,000 Individual Case Safety Reports (ICSRs) annually across three reporting streams (spontaneous, clinical, and solicited), achieving 100% compliance for three consecutive years.
Process Optimization
Reduced the triage-to-submission time by 40% through the implementation of a priority scoring system, successfully meeting 99.8% of expedited reporting deadlines even during periods of peak volume.
Quality Excellence
Achieved 'zero findings' in two consecutive database audits by developing and implementing rigorous ICSR registration standards, which were subsequently adopted globally across the organization.
Education & Certifications
Master's in Pharmaceutical Sciences from Chitkara University (2012), achieving a GPA of 8.1.
BSc in Pharmaceutical Sciences from Sardar Bhagwan Singh PGI (2010).
Registered Pharmacist (Reg No. 34641), ensuring safe and effective medication practices.
Certified in Hudson Spot Coaching™ Performance Management, focusing on individual development.
Specialized training in Drug Safety: Pharmacovigilance, covering comprehensive adverse event management.
Completed PMI Agile Certified Practitioner Prep, enhancing project delivery efficiency.
Awards & Professional Memberships
Recognition
- Peer Recognition Award of the Quarter
- With Heart Team Award for Business/Performance Excellence
Lifetime Member
Indian Pharmacy Graduates Association (IPGA)
Professional Association
Indian Pharmaceutical Congress Association (IPCA)