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Pharmacovigilance Oracle Argus Safety Database 7.0
Certificate
In Chandigarh ()
Description
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Type
Certificate
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Duration
2 Months
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Internship
Yes
Our short term certification courses help students to be job ready in shorter span of time.
Course highlights:
Job oriented practical training on Pharmacovigilance
Practical hand on exposure to Oracle Argus safety 7.0
Internationally recognized Certification
100% placement assistance
Post training support
About this course
MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical
Reviews
Subjects
- Pharmacovigilance
- ARGUS
- Clinical Data Management
- SAS EIS Software
- Oracle Certification
Teachers and trainers (1)
Sunil Verma
Director – Pharmacovigilance Training (Corporate Services)
Mr. Sunil Verma is the Founder & CEO of ACI, a reputed and fastest growing Pharmacovigilance Training Management Company with national and international presence. ACI delivers Pharmacovigilance Professional Training Programs for fresher and also has strong base in corporate training services across emerging markets. ACI is rated amongst the top training company globally for its quality systems and compliance. For the last 5 years, Mr. Sunil has focused on delivering high quality training service to fresher, Pharmaceutical and CROs in Pharmacovigilance.
Course programme
The focus of the lectures is mainly on:
- History and over view of pharmacovigilance
- Introduction and responsibilities: USFDA, EMA and CDSCO
- Pharmacovigilance in India
- Clinical Development process
- Different phases of clinical Trials
- Adverse events and its types
- Drug Safety in clinical trials and post marketed drugs
- Different sources of Adverse events reporting
- Different types of AE reporting Forms
- Expedited reporting and its timelines
- Different departments working on Pharmacovigilance
- Roles and responsibilities of case receipt unit
- Roles and responsibilities of Triage unit
- Four factors for the reportable case
- Seriousness criteria of adverse event
- Expectedness or Listedness of adverse event
- Causality assessment of the adverse event
- Introduction to safety databases and different types
- Importance and procedure of duplicate check
- Case bookin or initiation
- Introduction to MedDRA and WHODD
- Narrative writing
- Case quality check, Medical review and its submission.
- The Qualified Person for Pharmacovigilance (QPPV)
- PSUR and its submission timelines.
Practical Training will be also provided on Oracle Argus Safety Database on the following topics:
Case processing
MeDRA coding & WHO DD coding
Duplicate Check and case initiation
SAE Narrative writing
Additional information
Pharmacovigilance Oracle Argus Safety Database 7.0