Structure

Week 1: Fundamentals of Drug Safety and Case Management

Class 1: Introduction to Drug Safety

• Overview of drug safety in pharmacovigilance and its importance in public health.
• Roles and responsibilities of a Drug Safety Associate.

Class 2: Individual Case Safety Reports (ICSR)

• Understanding ICSRs: spontaneous, solicited, and literature cases.
• Introduction to MedDRA coding for case processing and adverse event classification.

Week 2: Adverse Event Reporting and Causality Assessment

Class 1: Adverse Event Reporting Requirements

• Global regulations and compliance for adverse event (AE) reporting.
• Key differences between expedited and periodic reporting requirements.

Class 2: Causality Assessment

• Methods for assessing the relationship between adverse events and drugs.
• Practical scenarios for understanding causality tools and frameworks.

Week 3: Risk Management and Aggregate Reporting

Class 1: Aggregate Reports

• Basics of periodic safety update reports (PSUR) and their purpose in drug safety.
• Hands-on guidance for preparing and interpreting data for aggregate reports.

Class 2: Risk Management Basics

• Introduction to risk management plans (RMP) and the elements of REMS.
• Understanding risk mitigation strategies for safe drug use.

Week 4: Audits, Career Skills, and Role Preparation

Class 1: Preparing for Drug Safety Audits

• Best practices for handling pharmacovigilance audits and inspections.
• Importance of audit readiness and compliance documentation.

Class 2: Leadership Development and Career Preparation

• Building leadership skills for collaboration and communication in drug safety roles.
• Mock interviews and resume optimization tailored for Drug Safety Associate positions.

Tangible Benefits:

• ✔ Career Readiness in 4 Weeks
• ✔ Resume and Interview Prep
• ✔ On-the-Job Support

Career Benefits:

• 🌍 100% Remote Work Opportunities
• 💰 Salary Potential: $109,000 - $145,000