An Introduction to Drug Safety and Pharmacovigilance

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Program/Course ID: DS01 Enrollment Period: 12 months. Average Learning Time: ~. Additional Resources: Supplemental materials & activities. Credit Hours: 3 credits. Method of Training: Online, asynchronous, self-paced eLearning. Accessibility: 24/7 access to all program materials. Demonstration: Four (4) free trial courses are available. Group/Employee Training: Click here to request a quote or invoice. Final Assessment: Multiple choice; unlimited attempts. Certificate: Encrypted PDF with QR validation code.

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Saturday, May 16, 2026 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.

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Outline: Orientation Designed as an introduction to using the Zenosis courses, this session guides you through the different functions of The course interface, such as how to navigate and interact with the course material. Also provided are short tips on how to get the most from your e-learning experience. Introduction Describes what the course is about, sets out learning objectives, defines key terms and provides a brief overview of course content. Regulation and company organization Explains the rationale for modern drug safety / pharmacovigilance (PV) regulation and practice, describes international policy-making bodies and sources of regulatory guidance, and outlines company drug safety / PV organization, product safety databases and core safety information. Before a product is marketed Sets out the fundamentals of pre-marketing drug safety / PV: safety information for investigators, describing adverse effects, clinical trial reporting requirements, safety data in marketing applications, risk management planning, and product information. After a product is marketed Sets out the fundamentals of post-marketing PV: monitoring adverse drug reactions, license holders' reporting requirements, detecting and testing safety signals, assessing benefit/risk balance, risk minimization, communicating new safety information, product withdrawal. Review and further information Summarizes key points and provides links to important guidance documents and other reference sources. Assessment Multiple-choice mastery assessment.		Objectives: Explain, with examples, why drug safety monitoring / pharmacovigilance is necessary Describe ways in which drug safety / pharmacovigilance is regulated nationally and internationally, and identify international policy-making bodies Outline how drug safety / pharmacovigilance responsibilities are organized within pharmaceutical and biotechnology companies Sketch how a product safety database is compiled, how a product's safety profile is assessed, and how safety information is included in documentation for regulatory authorities, healthcare professionals, and consumers Apply appropriate terms to describe different types of adverse effect Specify requirements to report adverse reactions to regulators Outline requirements for safety data and for risk management plans in applications for marketing approval List tasks involved in monitoring adverse reactions to marketed products, and sketch how safety signals are detected and tested Identify factors that influence the evaluation of a product's benefit/risk balance, and list actions that may be taken in response to changes in the balance

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Benefits of Training with Biopharma Institute

Immediate Course Access:	Login details, instructions, and payment confirmation are emailed immediately upon online enrollment.
Self-Paced eLearning:	Enjoy 24/7 access to all course materials and assessments for 12 months.
Open Enrollment:	No prerequisites or prior work experience required to start.
Expert-Developed Content:	Courses are designed by subject matter experts (SMEs) in their respective fields.
Up-to-Date & Validated:	Training is regularly updated to meet current regulations and is third-party validated or accredited.
Optimized for Learning:	Courses feature voiceovers, intuitive navigation, reading materials, case studies, progress checks, and animations to boost knowledge retention.
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Flexible Assessments:	Multiple-choice exams can be retaken until a passing score is achieved.
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Comments: For quotes or invoices please provide the titles of the course(s) and number of students.	An Introduction to Drug Safety and Pharmacovigilance