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Pharmacovigilance

With this online /in-person practical training, you will be able to apply for Pharmacovigilance positions including:

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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