Glossary entry (derived from question below)
French term or phrase:
Vigilance des essais cliniques
English translation:
(Pharmacovigilance Officer) Clinical Trial Surveillance/Monitoring
Added to glossary by
joanna menda
Apr 26, 2019 16:49
5 yrs ago
7 viewers *
French term
Vigilance des essais cliniques
French to English
Medical
Medical: Pharmaceuticals
SAE email
Hi,
This is a doctor's position. Under her name I have the following:
"Pharmacovigilant - Praticien Hospitalier - Vigilance des essais cliniques"
Could it be "clinical trial auditor"?
This is for the US.
Thanks
Joanna
This is a doctor's position. Under her name I have the following:
"Pharmacovigilant - Praticien Hospitalier - Vigilance des essais cliniques"
Could it be "clinical trial auditor"?
This is for the US.
Thanks
Joanna
Proposed translations
(English)
4 +7 | (Pharmacovigilance Officer) Clinical Trial Surveillance/Monitoring | Sue Davis |
3 +3 | Overseeing clincal trials | B D Finch |
3 +1 | head/manager of clinical trials | Barbara Cochran, MFA |
Proposed translations
+7
14 hrs
Selected
(Pharmacovigilance Officer) Clinical Trial Surveillance/Monitoring
I think vigilance has to be translated in the context of the pharmacovigilance role
--------------------------------------------------
Note added at 14 hrs (2019-04-27 07:03:27 GMT)
--------------------------------------------------
Sorry missed out Hospitap Practitioner
--------------------------------------------------
Note added at 14 hrs (2019-04-27 07:05:07 GMT)
--------------------------------------------------
As the appointee is a hospital doctor it isn't a full-time job.
--------------------------------------------------
Note added at 14 hrs (2019-04-27 07:06:03 GMT)
--------------------------------------------------
https://gradireland.com/careers-advice/job-descriptions/phar...
Introduction
The pharmacovigilance officer is responsible for the monitoring and reporting of the effectiveness and any adverse effects or side effects of pharmaceutical products on the market in the general population and in hospitals and research trials. They must liaise closely with medical and drug company representatives, patients, doctors and other healthcare professionals to record the effectiveness of drugs and other treatments. The data is meticulously recorded, analysed and processed because the informed opinions of pharmacovigilance officers will help the company maximise product safety and performance and cut down on adverse effects.
--------------------------------------------------
Note added at 14 hrs (2019-04-27 07:09:58 GMT)
--------------------------------------------------
Surveillance is used in an official EMA document
https://www.ema.europa.eu/en/documents/regulatory-procedural...
Recommendation on pharmacovigilance surveillance and
signal detection of veterinary medicinal products
--------------------------------------------------
Note added at 14 hrs (2019-04-27 07:11:04 GMT)
--------------------------------------------------
http://apps.who.int/medicinedocs/en/m/abstract/Js22109en/
Standard Operating Procedures. Active Pharmacovigilance Surveillance: Drug Safety Monitoring for New Medicines and Novel Regimens of the National TB Program in the Philippines
(2015; 21 pages)
Management Sciences for Health (MSH). Standard Operating Procedures. Active Pharmacovigilance Surveillance: Drug Safety Monitoring for New Medicines and Novel Regimens of the National TB Program in the Philippines. Manila, Philippines: MSH; 2015.
--------------------------------------------------
Note added at 14 hrs (2019-04-27 07:27:40 GMT)
--------------------------------------------------
Useful EMA site
https://www.ema.europa.eu/en/human-regulatory/overview/pharm...
Pharmacovigilance: Overview Share
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. The European Medicines Agency (EMA) coordinates the European Union (EU) pharmacovigilance system and operates services and processes to support pharmacovigilance in the EU.
--------------------------------------------------
Note added at 14 hrs (2019-04-27 07:31:35 GMT)
--------------------------------------------------
http://crisco.unicaen.fr/des/synonymes/vigilance
--------------------------------------------------
Note added at 16 hrs (2019-04-27 09:02:10 GMT)
--------------------------------------------------
ie 'keeping a watch on .......
'https://dictionary.reverso.net/english-synonyms/vigilance
--------------------------------------------------
Note added at 21 hrs (2019-04-27 14:32:32 GMT)
--------------------------------------------------
might be Pharmacovigilance Physician although the text doesn't say that.
--------------------------------------------------
Note added at 14 hrs (2019-04-27 07:03:27 GMT)
--------------------------------------------------
Sorry missed out Hospitap Practitioner
--------------------------------------------------
Note added at 14 hrs (2019-04-27 07:05:07 GMT)
--------------------------------------------------
As the appointee is a hospital doctor it isn't a full-time job.
--------------------------------------------------
Note added at 14 hrs (2019-04-27 07:06:03 GMT)
--------------------------------------------------
https://gradireland.com/careers-advice/job-descriptions/phar...
Introduction
The pharmacovigilance officer is responsible for the monitoring and reporting of the effectiveness and any adverse effects or side effects of pharmaceutical products on the market in the general population and in hospitals and research trials. They must liaise closely with medical and drug company representatives, patients, doctors and other healthcare professionals to record the effectiveness of drugs and other treatments. The data is meticulously recorded, analysed and processed because the informed opinions of pharmacovigilance officers will help the company maximise product safety and performance and cut down on adverse effects.
--------------------------------------------------
Note added at 14 hrs (2019-04-27 07:09:58 GMT)
--------------------------------------------------
Surveillance is used in an official EMA document
https://www.ema.europa.eu/en/documents/regulatory-procedural...
Recommendation on pharmacovigilance surveillance and
signal detection of veterinary medicinal products
--------------------------------------------------
Note added at 14 hrs (2019-04-27 07:11:04 GMT)
--------------------------------------------------
http://apps.who.int/medicinedocs/en/m/abstract/Js22109en/
Standard Operating Procedures. Active Pharmacovigilance Surveillance: Drug Safety Monitoring for New Medicines and Novel Regimens of the National TB Program in the Philippines
(2015; 21 pages)
Management Sciences for Health (MSH). Standard Operating Procedures. Active Pharmacovigilance Surveillance: Drug Safety Monitoring for New Medicines and Novel Regimens of the National TB Program in the Philippines. Manila, Philippines: MSH; 2015.
--------------------------------------------------
Note added at 14 hrs (2019-04-27 07:27:40 GMT)
--------------------------------------------------
Useful EMA site
https://www.ema.europa.eu/en/human-regulatory/overview/pharm...
Pharmacovigilance: Overview Share
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. The European Medicines Agency (EMA) coordinates the European Union (EU) pharmacovigilance system and operates services and processes to support pharmacovigilance in the EU.
--------------------------------------------------
Note added at 14 hrs (2019-04-27 07:31:35 GMT)
--------------------------------------------------
http://crisco.unicaen.fr/des/synonymes/vigilance
--------------------------------------------------
Note added at 16 hrs (2019-04-27 09:02:10 GMT)
--------------------------------------------------
ie 'keeping a watch on .......
'https://dictionary.reverso.net/english-synonyms/vigilance
--------------------------------------------------
Note added at 21 hrs (2019-04-27 14:32:32 GMT)
--------------------------------------------------
might be Pharmacovigilance Physician although the text doesn't say that.
Peer comment(s):
agree |
Rachel Fell
1 hr
|
Thanks Rachel!
|
|
agree |
Nikki Scott-Despaigne
3 hrs
|
Thanks Nikki!
|
|
agree |
abe(L)solano
: Yes, much better! Don´t now exactly at what level this person was involved.
3 hrs
|
Thanks!
|
|
agree |
writeaway
4 hrs
|
Thanks writeaway!
|
|
agree |
Gareth Callagy
1 day 9 hrs
|
Thanks!
|
|
agree |
Michele Fauble
1 day 11 hrs
|
Thanks!
|
|
agree |
El Mehdi Hakkou
2 days 1 hr
|
4 KudoZ points awarded for this answer.
Comment: "Thanks Sue!"
+1
7 mins
head/manager of clinical trials
In the sense of monitoring them to make sure they're being carried out correctly.
--------------------------------------------------
Note added at 9 mins (2019-04-26 16:58:29 GMT)
--------------------------------------------------
https://www.topmastersinhealthcare.com/job-profiles/clinical...
--------------------------------------------------
Note added at 10 mins (2019-04-26 16:59:44 GMT)
--------------------------------------------------
"clinical trials manager"
--------------------------------------------------
Note added at 9 mins (2019-04-26 16:58:29 GMT)
--------------------------------------------------
https://www.topmastersinhealthcare.com/job-profiles/clinical...
--------------------------------------------------
Note added at 10 mins (2019-04-26 16:59:44 GMT)
--------------------------------------------------
"clinical trials manager"
+3
15 mins
Overseeing clincal trials
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5101947/
by KL Hudson - 2016 - Cited by 64 - Related articles
As a crucial first step, NIH will require Good Clinical Practice (GCP) training for investigators and NIH staff responsible for conducting or overseeing clinical trials.
https://www.cancer.org/.../clinical-trials/what.../protectio...
... upheld by individuals and groups at the sites conducting research, and also by government agencies charged with overseeing clinical trials.
by KL Hudson - 2016 - Cited by 64 - Related articles
As a crucial first step, NIH will require Good Clinical Practice (GCP) training for investigators and NIH staff responsible for conducting or overseeing clinical trials.
https://www.cancer.org/.../clinical-trials/what.../protectio...
... upheld by individuals and groups at the sites conducting research, and also by government agencies charged with overseeing clinical trials.
Peer comment(s):
agree |
Bashiqa
: Fits the bill.
11 mins
|
Thanks Bashiqa
|
|
agree |
Drmanu49
19 mins
|
Thanks Drmanu
|
|
agree |
philgoddard
: But I think a noun would be more appropriate, so oversight
38 mins
|
Thanks phil. I find it more natural in this context to use "overseeing", but either would be OK.
|
Discussion