PHARMACOVIGILANCE IN AI ENVIRONMENT (PVAI)

Pharmacovigilance in AI Environment

Introduction – Pharmacovigilance Operations and Automation in AI Environment

Pharmacovigilance (PV) is evolving rapidly with the integration of Artificial Intelligence (AI) and Machine Learning (ML). Traditional PV workflows such as case intake, coding, signal detection, and reporting are now being enhanced by AI to deliver greater speed, accuracy, and compliance.

The Pharmacovigilance in AI Environment (PVAI) program prepares learners to understand and apply AI technologies in pharmacovigilance operations. It blends PV regulatory foundations with AI-driven innovations, enabling professionals to transition into next-generation drug safety roles.

SIP – Self-Paced Online with Support

Course Duration

PVAI-SIP Delivery – 8 Weeks / 140 Hours (Self-Paced)

Key Learning Objectives

1. Understand how AI integrates into PV workflows across clinical trials and post-marketing.
2. Explore automation in ICSR case intake, triage, and follow-up.
3. Learn how NLP supports narrative writing and literature monitoring.
4. Gain knowledge of AI-assisted MedDRA/WHO-DD coding.
5. Apply AI tools for signal detection, benefit–risk assessment, and risk management.
6. Examine AI-enabled PV databases such as Argus, ArisG, and Veeva Safety.
7. Learn compliance requirements (ICH-E2B, FDA, EMA, GDPR, HIPAA) for AI-driven PV.
8. Review case studies of AI-enabled pharmacovigilance in pharma and CROs.

1. Drug Safety Associates (DSAs) & PV Specialists preparing for AI-enhanced roles.
2. Medical Reviewers & Scientists integrating AI into safety case review.
3. Clinical Data Managers expanding into PV automation.
4. Data Analysts / AI professionals entering pharma safety.
5. Career changers moving into intelligent PV roles.

1. Gain practical skills in AI-enabled pharmacovigilance workflows.
2. Automate case processing, coding, narratives, and reporting tasks.
3. Build readiness for AI-driven safety and compliance roles in pharma and CROs.
4. Enhance employability in digital PV and global safety operations.
5. Be prepared for the future of intelligent and automated drug safety systems.

Graduates will be ready to pursue AI-enabled Pharmacovigilance roles in pharma, biotech, CROs, and regulatory organizations, including:

Entry-Level Roles:

1. Drug Safety Associate (DSA)
2. Pharmacovigilance Associate (PVA)
3. Case Processing Specialist
4. Medical Data Reviewer

Mid-Level Roles:

1. Signal Detection Analyst
2. Aggregate Report Specialist (PSUR/CIOMS)
3. Safety Operations Analyst
4. Risk Management Associate

AI-Driven Specialist Roles:

1. PV Automation Specialist
2. MedDRA Coding Analyst
3. Safety Systems and AI Workflow Analyst
4. RWE and AI Data Insights Specialist

After completing PVAI, learners gain exclusive access to Qtech-Sol’s Resume Marketing Services (RMS)—designed to connect skilled candidates with hiring partners.

Our post-training assistance includes:

1. Resume and LinkedIn Optimization: Tailored for AI-PV profiles highlighting both safety and automation skills.
2. Mock Interviews and Skill Assessments: Focused on AI-driven pharmacovigilance workflows and compliance.
3. Market Intelligence and Job Strategy Sessions: Personalized guidance for job targeting and industry readiness.
4. Direct Resume Promotion: Active marketing to partner networks and employers.

The PVAI program blends scientific knowledge with digital automation through the following modules:

1. Core Pharmacovigilance Foundations (20 Lessons)
2. Introduction to Drug Development and Pharmacovigilance – Understand drug safety within the development lifecycle.
3. ICH-GCP and Global Safety Regulations – Learn ethical and operational PV standards.
4. Adverse Event (AE) and Serious Adverse Event (SAE) Concepts – Identify, classify, and assess AEs/SAEs.
5. Case Processing Workflow – Perform end-to-end safety case handling.
6. MedDRA and WHO-DD Coding – Apply coding dictionaries for AE and drug classification.
7. Causality and Expectedness Assessment – Determine the likelihood of drug-event relationships.
8. Data Entry and Quality Checks – Ensure compliant data entry in Argus or ArisG systems.
9. Narrative Writing and Case Summarization – Develop clear and regulatory-compliant narratives.
10. Signal Detection and Risk Management – Detect and monitor emerging safety signals.
11. PSUR and PBRER Preparation – Learn aggregate report structure and timelines.
12. CIOMS and E2B (R3) Reporting – Understand case submissions and data exchange.
13. Audit Readiness and Quality Assurance – Build inspection and documentation skills.
14. HIPAA and Data Privacy Compliance – Maintain patient data confidentiality.
15. SAE Reconciliation and Data Integrity – Validate consistency between clinical and PV systems.
16. Vendor Oversight and Outsourced Safety Management – Manage third-party compliance.
17. Communication in PV Operations – Develop professional documentation and communication.
18. CAPA in Pharmacovigilance – Understand deviation management and corrective actions.
19. Introduction to Post-Market Surveillance – Monitor product safety post-launch.
20. Device and Combination Product Safety – Learn safety monitoring requirements.
21. Global Regulatory Submissions (FDA, EMA, MHRA) – Review regional safety submission expectations.

For more information, please call us at +1 732.770.4100 / +1 732.207.4564 (WhatsApp) or email qpdc@qtech-solutions.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.