Understanding Drug Safety: Foundations of Pharmacovigilance

Develop in-demand skills that extend beyond theory into real-world application. Through a blend of live and self-paced online learning, you’ll gain insight into how pharmacovigilance protects patients, ensures compliance, and informs risk-benefit decisions in modern healthcare.

Program Details:

Length: 2 weeks

Time Needed

Two weeks of online learning (synchronous and asynchronous)
Approximately 8 total hours of instruction

Cost

MCPHS Alumni: $475 (Please email professionalstudies@mcphs.edu for your unique discount code)
Early Registration (by Dec 31): $500
Standard Registration (after Dec 31): $550

Program Roadmap:

Participate in the 4-module curriculum over two weeks, connecting with faculty and other professionals
Gain the practical pharmacovigilance skills needed to understand, report, and act on drug safety information in real world settings
Demonstrate foundational drug safety literacy and readiness, valuable for career advancement across the life science industry

Learning Outcomes

Develop foundational knowledge of pharmacovigilance concepts, terminology, and workflows
Explain the role of pharmacovigilance in monitoring drug safety from clinical development through post-market surveillance
Understand how organizations maintain compliance with agencies such as the FDA and EMA
Recognize common pharmacovigilance scenarios and how safety teams respond

Who should enroll?

This course is designed for professionals seeking a clear, practical understanding of drug safety and pharmacovigilance, particularly those who interact with safety-related data, decisions, or compliance requirements but are not specialists in the field.

Our students are:

Clinical operations and research professionals
Medical affairs, commercial, and marketing professionals
Quality, compliance, and manufacturing professionals
Early career professionals in the life sciences

Curriculum

Module 1: Introduction to Pharmacovigilance and the Drug Safety Landscape
Module 2: Adverse Event Identification, Intake, and Reporting
Module 3: Global Regulatory Expectations and Safety Compliance
Module 4: Signal Detection, Risk-Benefit Assessment, and Real-World Application

Faculty

Ameet Pawar, MBA

Ameet Pawar is a pharmaceutical safety and regulatory professional with more than 20 years of experience in pharmacovigilance, drug safety, regulatory intelligence, and R&D quality. He has spent the past nine years at Takeda in leadership roles spanning pharmacovigilance policy, regulatory intelligence, and R&D quality. Ameet also teaches pharmaceutical and regulatory sciences at Northeastern University College of Professional Studies. His teaching emphasizes connecting pharmacovigilance principles and regulatory requirements with real-world drug development and safety decision-making. Outside of his professional and teaching activities, Ameet enjoys distance running, fitness, and challenging himself through endurance events and tower climbs.