Pharmacovigilance Associate
Duration: 40 CPD Hours
Course description:
Designed for those that have none or very little experience of in the field of clinical research (BSc or Post Graduate qualification required- Nursing or Science). This course is comprehensive and supports those seeking a position within the industry in Drug Safety. Following completion of this course you will be able to work effectively as a member of the Drug Safety Teams within organisations. You will gain a firm knowledge and understanding of key legislation applicable to Pharmacovigilance globally. Estimated completion time 40 hours on-line.
Elements covered in this course:
- Drug safety and monitoring
- Laws in Pharmacovigilance
- Signal generation and detection
- Spontaneous Reports
- Good Reporting Practices
- Case Report Forms
- Case Series
- Descriptive Analysis of a Case Series
- Data Mining and Statistical Analysis
- Non-randomised Observational Studies
- Risk Management Training
- Pharmacovigilance Plan
- Further Laws & Guidance in Pharmacovigilance
- Guidelines on Good Pharmacovigilance Practice
- Adverse Events
- Adverse Drug Reactions
- General Reporting Time-lines for AE’s/SAE’s
- CIOMS, ICH, ISoP, WHO
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