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VigiServe Academy for Patient Safety
India
Registrace 18. 03. 2020
VigiServe Foundation is a registered NGO with no plans to monetize this CZcams Channel so that the users encounter minimal or no advertisements.
These training videos are intended to assist the viewer in improving their understanding of the topic presented in the video. While we attempt to thoroughly address specific topics, it is not possible to include discussion of everything necessary and relevant to the given topic in a presentation of this nature. Thus, this information must be understood as a tool for a high-level introduction to the topic rather than exhaustive information about the said topic which is defined by directives, regulations, and other draft guidance by the respective regulatory agencies. Finally, over time, regulators may modify rules and interpretations in light of new technology, information, or circumstances; to keep apprised of such developments, or to review information on a wide range of patient safety, you should visit regulatory web sites.
These training videos are intended to assist the viewer in improving their understanding of the topic presented in the video. While we attempt to thoroughly address specific topics, it is not possible to include discussion of everything necessary and relevant to the given topic in a presentation of this nature. Thus, this information must be understood as a tool for a high-level introduction to the topic rather than exhaustive information about the said topic which is defined by directives, regulations, and other draft guidance by the respective regulatory agencies. Finally, over time, regulators may modify rules and interpretations in light of new technology, information, or circumstances; to keep apprised of such developments, or to review information on a wide range of patient safety, you should visit regulatory web sites.
EcoPharmacovigilance
Ecopharmacovigilance is be defined as science and activities concerning the detection, assessment, understanding, and prevention of adverse effects or other problems related to pharmaceuticals in the environment, which affect human and other animal species.
zhlédnutí: 186
Video
Black Triangle Products and Black Box Warnings
zhlédnutí 448Před rokem
Caution / Additional Monitoring List of medicines under additional monitoring www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/medicines-under-additional-monitoring/list-medicines-under-additional-monitoring
Setting up a Pharmacovigilance System
zhlédnutí 1,2KPřed rokem
What resources are required for setting up a Pharmacovigilance System? www.whopvresources.org www.meddra.org/about-meddra/organisation/msso who-umc.org/whodrug/whodrug-global/
Country Specific Pharmacovigilance Requirements
zhlédnutí 960Před rokem
Variation in the Country Specific Pharmacovigilance Requirements
Effective Networking on LinkedIn - Pharmacovigilance Professionals
zhlédnutí 1,1KPřed rokem
Leveraging LinkedIn for searching jobs and effectively networking with peers.
Pharmacogenomics and its role in Patient Safety
zhlédnutí 1KPřed rokem
Personalized / Precision medicines
Role of the Regulatory Affairs in Pharmacovigilance
zhlédnutí 1,5KPřed rokem
The Regulatory Affairs department plays a vital role in the smooth functioning of the Pharmacovigilance activities
Role of Legal Team in Pharmacovigilance
zhlédnutí 277Před rokem
How can the legal team support the smooth functioning of the Pharmacovigilance department?
The Role of IT in Pharmacovigilance
zhlédnutí 426Před rokem
The Information Technology team plays a very important role in the smooth functioning of the Pharmacovigilance department
Triage process in Pharmacovigilance
zhlédnutí 5KPřed rokem
Book-In process for an adverse event report; assigning the priority.
Medical Review in Pharmacovigilance
zhlédnutí 4,8KPřed 2 lety
The role of a medical reviewer in Pharmacovigilance.
Literature Safety Monitoring
zhlédnutí 6KPřed 2 lety
Learn about the literature search and review process in Pharmacovigilance. www.pubmed.gov Search String: DRUG NAME AND ('adverse drug reaction'/exp OR 'adverse drug reaction' OR 'drug overdose'/exp OR 'drug overdose' OR 'drug misuse'/exp OR 'drug misuse' OR 'drug abuse' OR 'substance abuse'/exp OR 'substance abuse' OR 'pregnancy'/exp OR 'pregnancy' OR 'drug efficacy'/exp OR 'drug efficacy' OR '...
Quality Management System in Pharmacovigilance
zhlédnutí 4KPřed 2 lety
Quality Management System in Pharmacovigilance
Seriousness Assessment in Pharmacovigilance
zhlédnutí 2,1KPřed 2 lety
Seriousness Assessment in Pharmacovigilance
Pharmacovigilance Training - Company Personnel
zhlédnutí 771Před 2 lety
Pharmacovigilance Training - Company Personnel
Case Processing Lifecyle in Pharmacovigilance
zhlédnutí 15KPřed 2 lety
Case Processing Lifecyle in Pharmacovigilance
Audit Vs Inspection in Pharmacovigilance
zhlédnutí 2,7KPřed 2 lety
Audit Vs Inspection in Pharmacovigilance
Designing a good CV / Resume for the dream job in Pharmacovigilance
zhlédnutí 7KPřed 2 lety
Designing a good CV / Resume for the dream job in Pharmacovigilance
Vaccine Adverse Event Reporting System in the United States
zhlédnutí 359Před 2 lety
Vaccine Adverse Event Reporting System in the United States
Thank you
sir difference between medical coding and pv
Medical coding is only one of the aspects of Pharmacovigilance. Besides, there is medical coding even in medical transcription.
Sir make same video for qc interview
China GPV has been officially released in 2021, in which, a qualified responsible PV is required. A remarkable change. The guidance document on PSMF was established in 2022.
yes, this is an old video
Sir, from where I can do this course
www.vigiservefoundation.org/courses/
Can you suggest me some project ideas for pharmacovigilance
You can consider analyzing the freely available safety data (regulatory agencies)
thanks a lot sir
great and very instructive sir.. thanks a lot..
I have an interview scheduled this Thursday. From my interview, I have gone through many pharmacovigilance materials, notes and videos to prepare myself fully. But trust me, this is the best video on CZcams, which you can rely on. This video really summarise everything that I have studied in the past few weeks. It has all the necessary topics along with your personality improvement. How to deal with situations and impress the interviewers. This video is remarkable and insightful for every aspirant who wants to join the Pharmacovigilance field. Thank you, sir. Lots of love for you. ❤❤❤❤❤
What is the starting salary in Pv? After 5yrs of exp what would be the salary?
Thanks for the thorough explanation. May I know the updated link to download IME list?
www.ema.europa.eu/en/human-regulatory-overview/research-development/pharmacovigilance-research-development/eudravigilance/eudravigilance-system-overview
Thanks
Nice video
Thank you for this video. can you add the reference please.
very useful, thank you! Looking forward to see more videos like this :)
Need to understand the process for literature review for the product marketed in INDIA. We are doing literature review through 2 website Indian Pharmacology and Dermatology sites
There is no point if these are indexed journals. Look for grey literature or journals published by various organizations (e.g., colleges)
Sir we need Ans for a ques Many interviewer asking wt is the use of isep certification course
isep? Could you please clarify?
This is so well and simply explained session. Thank you
Excellent Explanation Sir.I want your Mobile number...
www.linkedin.com/in/drmanojswaminathan/
Sir how to collect the case... It means the origin.....the first source...how and where....and when
Please check this: czcams.com/video/DtCATWo7Y_Q/video.html
Hi sir I got job as Senior Pv associate I have answered all questions after attending all your Pv videos Thank you so Much
You made our day! Thanks a ton!
Sir i m Master's in pharmacology And 13 year experience pharmacist work at mornings shift from 7 am to 1 pm Sir i wanted to do part time jobs?? What course is best for me To work from home Please suggested me something good
You can look at medical prescription
I have 1 question. … if company has 1000 cases, in this 1000 - 500 cases were unlisted aers… do does company do with this data?
they communicate to the regulatory agencies based on the country specific requirements
Sir I wana pursue certification course in pharamacovigilance. I am serching alot and confusef to pick a appropriate instuite. Now I am stuck between 2 instuite, IBRI- 6months certification course Or igmpi - 6 months executive diploma . Plz help
Join the one that assures you of a job!
Thanks so much for a detailed video on lit screening for ICSRs. Don't we consider a related/possible causality for a literature article to be valid along with the 4 min criteria?
Yes, you can consider Author's causality
Very good explanation
Very helpful
I recently watched your CZcams video related to pharmacovigilance and which is very useful and interesting when compared to other platforms they are providing this same course with certification, before weekend I completed pharmacovigilance basics -1 which boost my interest in this field Thank you sir
A very informative videos, thanku so much sir
Very helpful
Wonderful presentation
do you think pharmacovigilance need further investigation or research to cope with the health system third world country?
Yes indeed. We need to create awareness first followed by a system for reporting adverse events
Hello Sir. Can you tell me how many days does it take roughly to draft a PSUR and DSUR.
That completely depends on the product and the size of the safety data. In any case 4-6 weeks should be good
9:50 but PADER also dont talk about exposure ?? Please correct me if Im wrong...!!
As per 314.80, they don't.
Sir, Too good🎉
Hi Sir, can i have your contact please? Thank you
www.linkedin.com/in/drmanojswaminathan/
Nice Guideline about triage.
What is labelling mean here for case processing sir?
To check if an adverse event is expected to happen with a drug or not - Such documents are the labelling docs (e.g., package insert)
Can you please share video on report submission/gateway?
Yes, sure - it will take some time. In the meanwhile, please check czcams.com/video/GJpwmroCehU/video.html
Thanks sir
Sir you should also highlight some points regarding resume needs to be ATS friendly refrain yourself from making fancy resumes if it reduces your ATS Score..
Am bds with Msc in Clinical research with 1 year experience now .. how to apply for jobs in canada in pharmacovigilance there
You can consider searching on LinkedIn or other job portals. Else there might be consultancies which could help.
@@VigiServeAcademy thank you so much for the prompt reply... Appreciated... Have a Great Day God Bless 🙌🏻
Can we add certification from online free courses in our resume? If yes , can u suggest such PV courses???
Yes indeed! www.vigiservefoundation.org/inopp/topic/links-to-all-free-courses/
Thank you so much sir.it's very useful
Hellow Sir , i have completed bachelor degree in b pharmacy and also i have completed pg diploma in clinical research and pharmacovigelance i have good knowledge about pharmacovigelance as as fresher how can i enter i am trying to opportunity from last 4month no one can responce to me . I am confident about when anyone give me chance take my interview iam clear it but no one can give me chance
That is an essential question, Arjun. It is all about timing. The situation would have been different in 2020 or before. PHV is losing flavour these days - thanks to automation and AI/ML. The institute from where you pursued PGD might have promised hiring support. If they can offer some internship opportunities, that would be great. In the meantime, if you have some free time, then try learning some computer language like Python (using free resources). You can do this in parallel to your job hunt.
Sir I have a doubt.. Do we get certificate with the free courses on your website or do we have to pay upon completion for the certificate? Pls reply
Certificate is free
@@VigiServeAcademy Thank your sir🙏
Could you please give me a sample copy of PSMF?
These are highly confidential documents and hence not available on the social media
Very good session
Hello Sir , could u plz share insight if drug safety physicians can attend confrences worldwide or in india , where to check it and how to apply ?
There is nothing called 'application'. You pay the conference fee and enroll. One example: virtueinsight.com/event/pharmacovigilance-2023/
thanku for the valueable information sir, if one is already associated with CRO's , can it be attended complimentary as ticket price is really expensive ?@@VigiServeAcademy
Yes indeed. You can either ask your company to sponsor or reach out to the organizer for a discount if you are paying from your pocket. They would undoubtedly accommodate.
Thanku so much for the information sir @@VigiServeAcademy
Many thanks for the information sir :) @@VigiServeAcademy