Description
The Diploma in Pharmacovigilance & Signal Detection is a comprehensive online program covering pharmacovigilance, drug safety operations, safety case management and signal detection.
The program builds a foundation in pharmacovigilance before progressing to adverse event management, safety reporting, regulatory requirements, medical coding, risk management, signal detection and safety-data analysis.
Learners also receive structured training in Oracle Argus Safety for safety case management and Oracle Empirica Signal for signal detection, data mining and safety-data analysis.
This software-inclusive option provides 24×7 access to both Oracle Argus Safety and Oracle Empirica Signal, allowing learners to reinforce key concepts through hands-on software practice.
Program at a Glance
Pharmacovigilance | Argus Safety | Signal Detection | Empirica Signal
6 Months | 24×7 Software Access | Certificate on Completion
What You’ll Learn
- Understand the principles and processes of pharmacovigilance
- Explore adverse event and safety case management workflows
- Understand regulatory safety reporting requirements
- Learn medical coding concepts using MedDRA and WHODrug
- Understand individual case safety report processing
- Explore aggregate safety reporting and risk management concepts
- Understand the principles of signal detection and signal management
- Explore data mining and disproportionality analysis
- Develop familiarity with Oracle Argus Safety workflows
- Apply applicable safety case management activities using Oracle Argus Safety
- Understand Oracle Empirica Signal features and workflows
- Apply signal-detection and safety-data analysis concepts using Oracle Empirica Signal
Who Is This Program For?
- Students and graduates interested in pharmacovigilance and drug safety
- Pharmacovigilance professionals seeking broader drug safety knowledge
- Drug safety professionals interested in signal detection and safety analytics
- Clinical research professionals seeking knowledge of pharmacovigilance processes
- Pharmacy, life sciences, medical and healthcare graduates
- Professionals seeking exposure to Oracle Argus Safety and Oracle Empirica Signal
- Learners seeking combined pharmacovigilance, safety database and signal-detection training
Hands-On Pharmacovigilance Software Experience
This program combines structured pharmacovigilance and signal-detection training with 24×7 access to Oracle Argus Safety and Oracle Empirica Signal for the duration of the program.
The software environments allow learners to connect the concepts covered in the curriculum with their practical application in safety case management and signal analysis.
Oracle Argus Safety
Use Oracle Argus Safety to reinforce applicable pharmacovigilance workflows, including application navigation, safety case entry and processing, medical coding, case review, Advanced Conditions and safety reporting.
Hands-on practice helps learners understand how pharmacovigilance case-management activities are performed within a safety database environment.
Oracle Empirica Signal
Use Oracle Empirica Signal to reinforce signal-detection and safety-data analysis concepts through practical exposure to queries, case series, data mining runs, graphical analysis, drug profiles, reporting and signal-management Topics.
This allows learners to connect signal-management theory with its application in a pharmacovigilance analytics environment.
Software Access: Learners enrolled in this option receive 24×7 access to both Oracle Argus Safety and Oracle Empirica Signal for the duration of the 6-month program.
Explore the Software Used in This Program
New to pharmacovigilance software? Explore our free ClinSkill learning resources to understand how Oracle Argus Safety supports safety case management and how Oracle Empirica Signal supports signal detection and safety-data analysis.
Maria Kodzhabasheva –
I’m very happy with the completion of this program—it delivered exactly what I was looking for: hands-on experience with the software tools, along with a comprehensive end-to-end overview of the industry. Thank you for always being available to answer my questions and for providing clear, precise, and detailed explanations throughout!