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Pharmacovigilance Industry Oriented Training Program

LIVE
8 reviews
Ongoing

Course offered by Sunil Verma

8 reviews
Practical training on Argus Safety Database 7.0 is provided with internationally recognized certifications with 100% placement assistance. This will give you jump in your career by joining this fastest growing industries of Clinical Research & Pharmacovigilance.

Topics Covered

• 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

Who should attend

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 companies, CROs and Hospitals.

Pre-requisites

Basic Medical Knowledge

What you need to bring

Nothing, all the stationary will be provided by institute.

Key Takeaways

Oracle Argus Safety Database 7.0 MedDRA & WHODD Medical Dictionaries

About the Trainer

5 Avg Rating

8 Reviews

8 Students

4 Courses

Sunil Verma

MBA, B.Pharmacy

Highly motivated and results-driven professional with over 10 years experience in Trainings, Project Management, Marketing, and Leadership. Practical Experience on Oracle Argus Safety Database 7.0 & MedDRA & WHODD Medical Dictionaries. Innovative, Strong presenter with proven ability to design and deliver training to a variety of individuals on topics ranging from Pharmacovigilance, Clinical Research, SAS, Clinical Data Management to Professional Development like Leadership, Team Work, Communication, Integrity, Performance etc.

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Reviews (8)

5 out of 5 8 reviews

Academy of Clinical Intelligence (ACI) https://www.urbanpro.com/assets/new-ui/institute-100X100.png Sector-8
5.0058
Academy of Clinical Intelligence (ACI)
H

Pharmacovigilance Industry Oriented Training Program

"Good place to begin career prospects with ACI"

Academy of Clinical Intelligence (ACI)
S

Pharmacovigilance Industry Oriented Training Program

"Best Institute for Practical Trainings in CDM, PV and SAS"

Academy of Clinical Intelligence (ACI)
S

Pharmacovigilance Industry Oriented Training Program

"Best Institute for Practical Trainings in CDM, PV and SAS"

Academy of Clinical Intelligence (ACI)
N

Pharmacovigilance Industry Oriented Training Program

"This is certainly training worth doing if you want to see the bigger picture. Doing my training at ACI on Pharmacovigilance was an invaluable experience. I gained practical experience on case processing with ARGUS Safety which enhanced my technical skills. It really worked and I am very excited to be starting my new career. Thank you very much ACI for all your support""

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5 out of 5 8 reviews

Academy of Clinical Intelligence (ACI) https://www.urbanpro.com/assets/new-ui/institute-100X100.png Sector-8
5.0058
Academy of Clinical Intelligence (ACI)
H

Pharmacovigilance Industry Oriented Training Program

"Good place to begin career prospects with ACI"

Academy of Clinical Intelligence (ACI)
S

Pharmacovigilance Industry Oriented Training Program

"Best Institute for Practical Trainings in CDM, PV and SAS"

Academy of Clinical Intelligence (ACI)
S

Pharmacovigilance Industry Oriented Training Program

"Best Institute for Practical Trainings in CDM, PV and SAS"

Academy of Clinical Intelligence (ACI)
N

Pharmacovigilance Industry Oriented Training Program

"This is certainly training worth doing if you want to see the bigger picture. Doing my training at ACI on Pharmacovigilance was an invaluable experience. I gained practical experience on case processing with ARGUS Safety which enhanced my technical skills. It really worked and I am very excited to be starting my new career. Thank you very much ACI for all your support""

Academy of Clinical Intelligence (ACI)
D

Pharmacovigilance Industry Oriented Training Program

"I would like to express my appreciation to Academy of Clinical Intelligence (ACI) for all the efforts they have made for my career success. The Pharmacovigilance training was as per the industry requirement and helped me to get skilled for the job and also get the entry in the world of Pharmacovigilance. I highly recommend Academy of Clinical Intelligence (ACI) to any individual or organization interested in expanding their job skills training need in Pharmacovigilance."

Academy of Clinical Intelligence (ACI)
M

Pharmacovigilance Industry Oriented Training Program

"The Pharmacovigilance training helped me to achieve my goals to start my career in Pharmacovigilance. It was a great experience and the training format is really impressive. The training has increased my confidence and technicalities for Pharmacovigilance job and later helped me to get the job. I wish ACI all the very best.”"

Academy of Clinical Intelligence (ACI)
D

Pharmacovigilance Industry Oriented Training Program

"I feel happy & satisfied about my decision to join ACI for PHARMACOVIGILANCE (PV) training program...The training i received was not only professional & complete, it was also technically superior...Teaching pattern was interacting so we got good exposure to practical now how..Our trainer Mr. Sunil Verma, sir is excellent and train us thoroughly in all aspects...Joining PV after BDS is an added advantage for me..I found this academy as a perfect environment conducive to effective learning & academic success...All in all, it was a great experience.”"

Academy of Clinical Intelligence (ACI)
D

Pharmacovigilance Industry Oriented Training Program

"I am fully satisfied by my decision of joining Academy of Clinical Research. Best place to increase your knowledge, self confidence and smartness if you are preparing to enter in the field of Pharmacovigilance."

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Pharmacovigilance Industry Oriented Training Program by Sunil Verma

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