Pharmacovigilance Industry Oriented Training in Oracle Argus Safety Database

Global Pharmacovigilance Training in Oracle Argus Safety Database

Organization at a Glance:

Gratisol Labs is a leading Clinical Research organization providing full range of Clinical Research, Clinical Data Management, CDISC SDTM, Pharmacovigilance & SAS training services to Healthcare Organizations globally. 

The classes will be conducted at ‘GRATISOL LABS’, Road No.10, Banjara Hills, Hyderabad.

The focus of the lectures will be mainly on the following topics:

• 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) in the European Economic Area
• PSUR and its submission timelines

Practical Training will be also provided on Safety Database on the following topics:

• Data Entry
• Case Processing 
• MedDRA & WHODD coding
• SAE narrative writing.

Mode of training- Instructor Led Class room/ Online Training

Note: Industry Experts from Novartis, Parexel, TechMahindra, Infosys, HCL, MakroCare, Aurobindo Pharma, Natco Pharma, Dr Reddys will deliver the classes.

Our candidates employed in Mahindra Satyam, GSK, Quanticate, ICMR, Global Hospitals, Apollo Hospitals, NIMS, Quintiles, Novartis, Glenmark Pharmaceuticals Ltd, Parexel International (India) Pvt Ltd, AstraZeneca-UK and many more…

To reserve the seat immediately, send a DD of Rs.500/- in favour of Gratisol Labs payable at Hyderabad along with your resume by courier or registered post. You can also reserve the seat by doing cash payment at Gratisol Labs Premises.

Tenure: 2 month

Eligibility

Applicants are recommended to have one of the following life Science degrees: Bachelor's, Master’s, or PhD, 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.Pharmacy, M.Sc /MA (Statistics) and all professionals  working with Pharmaceutical companies, CROs and Hospitals.

Certification

Certificate will be provided for this course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by Gratisol Labs.

For more information, please contact Gratisol Labs at [email protected]  

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