Certified Specialist Programme in Drug Safety
-- viewing nowDrug Safety is a critical area demanding specialized expertise. This Certified Specialist Programme equips professionals with the skills and knowledge essential for Pharmacovigilance and regulatory compliance.
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Course details
• Regulatory Requirements for Drug Safety
• Data Handling and Analysis in Drug Safety
• Signal Detection and Assessment
• Risk Management Planning and Implementation
• Case Processing and Causality Assessment
• Adverse Event Reporting and Documentation
• Pharmacoepidemiology and its application to drug safety
• Good Pharmacovigilance Practices (GVP)
• Legal and Ethical Considerations in Drug Safety
Career path
| Career Role (Drug Safety) | Description |
|---|---|
| Pharmacovigilance Specialist | Responsible for monitoring and assessing the safety of drugs post-market; adept at adverse event reporting and signal detection; crucial for patient safety and regulatory compliance. |
| Drug Safety Physician | Medical expert providing safety oversight in drug development and lifecycle management; crucial for risk assessment and benefit-risk evaluation. Strong medical knowledge and regulatory expertise are essential. |
| Drug Safety Scientist | Contributes to the safety assessment of pharmaceuticals, using scientific data analysis and regulatory knowledge; involved in risk management planning and documentation. |
| Safety Data Manager | Manages and analyzes large datasets related to drug safety; plays a critical role in ensuring data integrity and reporting accuracy. |
Entry requirements
- Basic understanding of the subject matter
- Proficiency in English language
- Computer and internet access
- Basic computer skills
- Dedication to complete the course
No prior formal qualifications required. Course designed for accessibility.
Course status
This course provides practical knowledge and skills for professional development. It is:
- Not accredited by a recognized body
- Not regulated by an authorized institution
- Complementary to formal qualifications
You'll receive a certificate of completion upon successfully finishing the course.
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