Certified Pharmacovigilance & Safety Officer (CPSO)

CPSO (PVSO-001) Exam Objectives

This exam certifies that the candidate has the knowledge to manage pharmacovigilance systems, ensure regulatory compliance, and contribute to the ongoing safety evaluation of medicinal products.

Domain 1: Pharmacovigilance Principles and Regulations (30%)

• Global Regulatory Framework: Describe the key pharmacovigilance regulations and guidelines from major health authorities (e.g., FDA, EMA, ICH).
• Pharmacovigilance System Master File (PSMF): Understand the purpose and components of the PSMF.
• Key Terminology: Define core concepts such as adverse drug reaction (ADR), serious adverse event (SAE), and expectedness.

Domain 2: Adverse Event Case Processing and Reporting (35%)

• Case Intake and Triage: Manage the receipt and initial assessment of adverse event reports from various sources.
• Data Entry and Narrative Writing: Accurately process case information into a safety database and write a medically coherent case narrative.
• Medical Coding: Apply coding principles using dictionaries such as MedDRA and WHO-DD.
• Expedited Reporting: Identify cases that meet the criteria for expedited reporting to regulatory authorities.

Domain 3: Signal Detection and Risk Management (25%)

• Signal Management: Describe the process of signal detection, validation, analysis, and assessment using aggregate safety data.
• Aggregate Reporting: Understand the purpose and components of periodic safety reports (e.g., PSURs, PADERs).
• Risk Management Planning: Develop and manage Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).

Domain 4: Safety Communication and Audits (10%)

• Safety Labeling: Participate in the process for updating a product's safety information in the company core data sheet and local labels.
• Audits and Inspections: Describe how to prepare for and participate in a regulatory pharmacovigilance inspection or internal audit.

Eligibility Requirements

To be eligible to sit for a CPS certification exam, candidates must meet the criteria outlined in one of the two pathways below.

Pathway 1: For U.S. Licensed Pharmacists

This pathway is for pharmacists licensed to practice within the United States, regardless of country of graduation.

• Hold an active and unrestricted pharmacist license in any state or territory of the United States.
• Meet educational requirements by being a graduate of an ACPE-accredited school of pharmacy or holding a Foreign Pharmacy Graduate Examination Committee® (FPGEC) Certificate.
• Fulfill the specialty experience requirement as outlined below.

Pathway 2: For International Pharmacists (Non-U.S. Licensed)

This pathway is for pharmacists who practice outside of the United States.

• Hold an active and unrestricted license to practice pharmacy in their country of practice. A certified English translation of the license must be provided if the original is not in English.
• Hold a professional degree in pharmacy equivalent to a U.S. pharmacy degree, such as a Bachelor’s degree (BPharm), Master’s degree in Pharmacy Practice (MPharm), or Doctor of Pharmacy degree (PharmD).
• Fulfill the specialty experience requirement as outlined below.

Specialty Experience Requirement (for all pathways)

To ensure candidates have foundational knowledge in the specialty, one of the following criteria must be met:

• Standard Pathway:
  Completion of at least one year of professional experience in a practice setting directly related to the certification area.
• Certificate Pathway:
  The one-year specialty experience requirement is waived for candidates who hold an active certificate of completion from a nationally recognized provider in a related subject matter. This includes, but is not limited to, the completion of a relevant PGY residency, fellowship, certificate/training program, or a relevant graduate degree (e.g., a Master's degree in the specialty field). Recognized providers of certificate programs include, but are not limited to:
  • American Society of Health-System Pharmacists (ASHP)
  • American Pharmacists Association (APhA)
  • American College of Clinical Pharmacy (ACCP)
  • American Society of Consultant Pharmacists (ASCP)

Career Path for CPSO Professionals

The CPSO certification is for pharmacists and other healthcare professionals working in drug safety and pharmacovigilance within the biopharmaceutical industry, contract research organizations (CROs), or regulatory agencies.

Target Candidates

• Pharmacists working in drug safety or pharmacovigilance at a pharmaceutical company or CRO.
• Pharmacists with experience in medication safety or regulatory affairs seeking to specialize.
• Professionals with a background in clinical research or public health.

Primary Job Roles:

• Drug Safety / Pharmacovigilance Scientist
• Medical Reviewer, Safety
• Pharmacovigilance Officer
• Risk Management Specialist
• Medication Safety Pharmacist (Industry)

Career Advancement:

A CPSO is on a path to leadership in global drug safety. They can advance to become a Manager, Director, or Vice President of Pharmacovigilance or Risk Management. Their expertise is critical for any company that develops and markets medicinal products.

Study Resources

Prepare for your CPSO exam with resources focused on the global practice of drug safety.