Description

This 8-module pharmacovigilance course is designed to equip participants with both technical knowledge and practical skills needed to manage drug safety in clinical and post-marketing phases. The course focuses on case management, regulatory compliance, and safety monitoring to ensure participants are ready for real-world pharmacovigilance roles.

Module 1: Introduction to Pharmacovigilance and Regulatory Frameworks

• Overview of pharmacovigilance and its importance in public health
• Introduction to ICSR (Individual Case Safety Reports)
• Key regulatory bodies: EMA, FDA, MHRA, CDSCO
• International guidelines: ICH E2E, WHO pharmacovigilance frameworks

Module 2: Case Management and Adverse Event Reporting

• End-to-end case processing: data entry, triage, quality review, and reconciliation
• Types of adverse events: serious, non-serious, expected, unexpected
• Narrative writing: Clear and concise reporting of medical events
• Manual coding using MedDRA (Medical Dictionary for Regulatory Activities)

Module 3: Drug Safety Database Management and SOPs

• Configuring and maintaining drug safety databases (e.g., Argus, ArisG)
• Study-specific safety management plans (SMPs) and tools
• Developing and adhering to Standard Operating Procedures (SOPs)
• Tracking systems for submission timelines and compliance monitoring

Module 4: Regulatory Reporting Requirements and Compliance

• Expedited ICSR reporting obligations (15-day and 7-day reports)
• Overview of PSUR, DSUR, and PBRER reports
• Compliance tracking: timelines for adverse event submissions
• Monitoring regulatory inquiries and ensuring timely responses

Module 5: Safety Monitoring and Risk Management

• Conducting literature searches to identify safety signals
• Monitoring post-marketing safety commitments
• Collaborating with medical monitors and study teams on safety issues
• Managing and reconciling Investigational Product (IP) safety data

Module 6: Audit Readiness and Inspection Preparation

• Preparing for regulatory inspections and internal audits
• Maintaining audit readiness with proper documentation and processes
• Managing and resolving audit findings and CAPA (Corrective and Preventive Actions)
• Oversight of safety compliance in CRO and pharmaceutical environments

Module 7: Cross-Functional Collaboration and Leadership Development

• Working with global project teams and managing deliverables
• Communication with clients and regulatory authorities
• Oversight and mentoring junior staff in pharmacovigilance processes
• Developing soft skills: leadership, teamwork, and project management

Module 8: Final Assessment and Career Preparation

• Mock assessments with case studies and practical scenarios
• CV building and interview preparation for pharmacovigilance roles
• Career paths: Safety Officer, PV Manager, PV Scientist
• Industry trends: Automation, AI in PV, and remote monitoring