Pharmacovigilance
With this online /in-person practical training, you will be able to apply for Pharmacovigilance positions including:
- Drug Safety Associate (DSA)
- Pharmacovigilance Associate
- Pharmacovigilance officer
- Pharmacovigilance Specialist
- Aggregate report writer
- Medical Review/ Quality Reviewer (MR/QR)
- Drug Safety Physician (DSP)
- Pharmacovigilance Coordinator
- Pharmacovigilance System Specialist
| S.no | Theoretical Training |
|---|---|
|
1 |
Drug Development process |
|
2 |
Definition, History, Overview and Basic terminologies of Pharmacovigilance |
|
3 |
Pharmacovigilance workflow |
|
4 |
Different sources of Adverse events and Reporting forms for Different Regulatory agencies |
|
5 |
India and Global Guidelines and Submission timelines |
|
6 |
Individual case safety report (ICSR) |
|
7 |
Four Valid criteria for a reportable case |
|
8 |
Medical Confirmation, Seriousness, Action taken, Event Outcome, De-challenge and Rechallenge |
|
9 |
Causality and Expectedness |
|
10 |
Signal detection |
|
11 |
ICH-GCP |
|
12 |
MedDRA Coding and MedDRA Points to Consider |
|
13 |
Narrative writing |
|
14 |
Aggregate report preparation |
|
15 |
Medical Literature monitoring |
| S.no | Practical Training using Clinevo Safety Database |
|---|---|
|
1 |
Clinevo Safety PV database overview |
|
2 |
Different icons used during the case processing and their purpose. |
|
3 |
Different tabs used in case processing |
|
4 |
Case Routing Based on workflow |
|
5 |
Minimum requirements for a case booking |
|
6 |
Cases from Clinical Trials, Spontaneous and Literature |
|
7 |
Case Processing |
|
8 |
Duplicate case check or verification |
|
9 |
Case Booking and Data entry |
|
10 |
Narrative Writing |
|
11 |
MedDRA and WHO DD coding |
|
12 |
Case Routing |
|
13 |
Case Quality check |
|
14 |
Medical review of Individual Case Safety Reports (ICSRs) |
|
15 |
Report Generation for Regulatory Submission |
|
16 |
Expedited Reports (CIOMS 1, MedWatch and E2B) |
|
17 |
Aggregate Reports (Periodic reports and Line Listing) |
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