Stufenplanbeauftragter

English translation: graduated plan officer

16:18 Dec 4, 2006
German to English translations [PRO]
Medical - Medical: Pharmaceuticals / Pharmacovigilance
German term or phrase: Stufenplanbeauftragter
Hello everybody,
My customer insists that there is a specific term for this job title in English (only he has no idea what it is...).
It is used in connection with pharmacovigilance and describes the person in charge of the stepped plan regarding risk assessment for veterinary drugs.
Any idea?
Sonia Rowland
Local time: 06:16
English translation:graduated plan officer
Explanation:
does exist, although I also have "pharmaco-vigilance manager / drug safety manager" in my own glossary
Selected response from:

Jonathan MacKerron
Grading comment
Selected automatically based on peer agreement.
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +2graduated plan officer
Jonathan MacKerron
4risk management plan officer
ciliegina
4Qualified Person for Pharmacovigilance
Johanna Timm, PhD
1 +1Manager - medical affairs
Zareh Darakjian Ph.D.


  

Answers


21 mins   confidence: Answerer confidence 1/5Answerer confidence 1/5 peer agreement (net): +1
Manager - medical affairs


Explanation:
I found the following site where it is transated as "Manager - medical affairs". Mine is just a guess based on this...

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Note added at 21 mins (2006-12-04 16:40:25 GMT)
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http://www.pharmalex.de/files/rz2_anz_pex_4c_005.pdf

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Note added at 25 mins (2006-12-04 16:43:57 GMT)
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** MANAGER MEDICAL AFFAIRS/ **
PHARMACOVIGILANCE/
** STUFENPLANBEAUFTRAGTER (m/w) **
IHRE AUFGABEN:
• Selbständiges Erstellen der präklinischen und klinischen Module
von Zulassungsdossiers
• Erstellung von pharmakologisch-toxikologisch und klinischen Gutachten
• Selbständige Planung und Durchführung von
„Clinical Trial Applications“
• Planungsunterstützung im Bereich Clinical Development
• Mitarbeit bei der Erarbeitung, Gestaltung und Validierung
medizinisch-wissenschaftlicher Produktaussagen
• Zusammenarbeit mit firmeninternen internationalen Arbeitsgruppen
• Planung, Implementierung und Überwachung organisatorischer
Strukturen für das Sammeln und Dokumentieren von
Arzneimittelrisiken.
• In Ihrer Verantwortung als Stufenplanbeauftrager die Übernahme
der Meldepflicht an die zuständige Bundesbehörde gem. AMG,
die Erstellung entsprechender SOPs sowie die Bewertung der
Arzneimittelrisiken nach dem aktuellen Wissensstand
UNSERE ERWARTUNGEN:
• Erfolgreicher Abschluss einer medizinischen Ausbildung
(idealerweise Humanmedizin mit ggf. pharmakologischer Erfahrung)
• Erfahrung im Bereich „Medical Writing“
• Fließende Englischkenntnisse in Wort und Schrift
• Gute EDV Kenntnisse
• Selbständigkeit, Flexibilität und Leistungsbereitschaft
• Kommunikationsstärke, Sozialkompetenz, Integrationsfähigkeit
• Hohes Verantwortungsbewusstsein, Organisationstalent
und Eigenmotivation
UNSER ANGEBOT:
• Interessante, abwechslungsreiche Aufgabe mit Kundenkontakt
• Attraktives Einkommen
• Gute Entwicklungsmöglichkeiten
• Angenehmes, offenes Betriebsklima
Wenn wir Ihr Interesse geweckt haben, dann freuen wir uns auf Ihre
aussagefähigen Unterlagen mit Angabe Ihrer Gehaltsvorstellung und
Ihres frühestmöglichen Eintrittstermines.
Für telefonische Rückfragen stehen Ihnen Frau Dr. von Fritschen und
Frau Dr. Hanke gerne zur Verfügung: Tel 0621.181538-0
PPhhaarrmmaaLLeexxGmbH, Joseph-Meyer-Str. 13–15, 68167 Mannheim

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Note added at 26 mins (2006-12-04 16:44:54 GMT)
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O better, I think:

Manager of medicall affairs and pharmacovigilance

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Note added at 26 mins (2006-12-04 16:45:27 GMT)
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Sorry: "medical"

Zareh Darakjian Ph.D.
United States
Local time: 21:16
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in ArmenianArmenian
PRO pts in category: 112

Peer comments on this answer (and responses from the answerer)
agree  Hamza Gürdal
14 mins
  -> Thank you, very much, tandem2007!

neutral  Cilian O'Tuama: sounds too general to me //I mean the term itself, not the job description
7 hrs
  -> Yes, Cilian. I later added: Manager of medical affairs and pharmacovigilance.
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3 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +2
graduated plan officer


Explanation:
does exist, although I also have "pharmaco-vigilance manager / drug safety manager" in my own glossary

Jonathan MacKerron
Specializes in field
Native speaker of: English
PRO pts in category: 180
Grading comment
Selected automatically based on peer agreement.
Notes to answerer
Asker: Hiya Jonathan, As there doesn't seem to be an equivalent to this job the world over, the consensus was among the people involved was to leave the German title in italics and describe it in square brackets.

Asker: Dear Zareh, Please see my comment to Jonathan. Thanks a lot after all, though.


Peer comments on this answer (and responses from the answerer)
agree  Cilian O'Tuama: I've got drug safety officer in mine (though I like pharmacovigilance officer, too)
4 hrs

agree  Sabine Griebler: I can confirm pharmaco-vigilance manager and drug safety manager
13 hrs
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7 days   confidence: Answerer confidence 4/5Answerer confidence 4/5
risk management plan officer


Explanation:
I know this a late answer but I just came across this as I was looking for the Stufenplanverfahren. The "official" translation on the BfArM website is risk management plan.


Example sentence(s):
  • Within a risk management action (Stufenplan) the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) has ruled that the product informations on medicinal products for hormone replacement therapy (H

    Reference: http://www.bfarm.de/cln_042/nn_421146/sid_68B8F887A1DF96FAE8...
ciliegina
United Kingdom
Local time: 05:16
Native speaker of: Native in EnglishEnglish
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4233 days   confidence: Answerer confidence 4/5Answerer confidence 4/5
Qualified Person for Pharmacovigilance


Explanation:


as shown in this site (toggle the tabs for English/German):
https://www.diapharm.com/en/medicinal-products/pharmacovigil...

Johanna Timm, PhD
Canada
Local time: 21:16
Native speaker of: Native in GermanGerman
PRO pts in category: 121
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