Stellenangebot als Pharmacovigilance Manager, Drug Safety, Pharma & Biotech in Deutschland (Gigajob-Deutschland)
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Alle Pharmacovigilance Manager - Jobs in Deutschland
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Pharmacovigilance Manager, Drug Safety, Pharma & Biotech

Arbeitsort: Deutschland
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Anbieter:
SIRE Life Sciences
Arbeitsverhältnis:
Festanstellung
Arbeitszeit:
Vollzeit
Vergütung:
monatliches Festgehalt
Anzeige vom:
10.12.2014 (1016 Tage alt)
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Anbieter
Arbeitgeber:
SIRE Life Sciences   Dieses Mitglied ist nicht geprüft.
Unternehmensbeschreibung
SIRE Life Sciences is a Recruitment & Executive Search Consultancy dedicated exclusively to the European Life Science industry. SIRE Life Sciences provides a “Complete-Life-Science-Cycle-Search-Solution” to both Life Science Professionals and Life Science Employers operating in the European Life Science sector. We offer a tailor made European-wide service for both Permanent or Freelance solutions specialized in delivering into the world’s leading Life Science institutions.

SIRE Life Sciences has highly skilled teams of Recruitment, Executive Search and Staffing Issues Specialist providing high premium in tailored Life Science recruitment solutions and advice on staffing issues particularly executive search and retention.

SIRE Life Sciences covers Freelance & Permanent Recruitment and Executive Search Consultancy in the European Life Science sectors:

Pharmaceuticals
Biotechnology
Medical Devices
Clinical Research Organisations
Healthcare
Food Science
Cosmetics
Chemicals
FMCG
SIRE Life Sciences offers recruitment, executive search and staffing issues consultants who are specialist within a:

Specific ‘niche’ market within the European Life Science sector
Technical profession within the European Life Science sector
Specific region within Europe
We name it the “3Dimensional SIRE Search Method” with the aim to find the best professionals fastest.
“Excellence in European Life Science employment solutions”
Anzahl der Mitarbeiter
11 - 100 Vollzeit-Mitarbeiter sind im Unternehmen beschäftigt
 
Stellenbeschreibung
Stellenbezeichnung
Pharmacovigilance Manager, Drug Safety, Pharma & Biotech
Jobbeschreibung
SIRE LIFE SCIENCES
SIRE Life Sciences is a recruitment and executive search consultancy, dedicated exclusively to the European Life Science industry. SIRE Life Sciences provides a Complete Life Science Cycle Search Solution to both Life Science Professionals and Life Science Employers operating in the European Life Science Sector. We provide a tailor made European wide service for both permanent and freelance solutions, specialized in delivering to the worlds leading Life Science institutions.

ROLE
Pharmacovigilance Manager, Drug Safety, Pharma & Biotech.

DESCRIPTION
For various Biotechnology and Pharmaceutical clients in Germany we are looking for Pharmacovigilance / Drug Safety professionals.

RESPONSIBILITIES
Evaluation and QC review of draft SAE reports.
Monitoring compliance of regulatory reports: SUSAR, ASRs and 6-monthly line listing including distribution lists and timelines.
Active management of pharmacovigilance service provider
Prepare, review and/or contribute to PV and safety containing documents (protocols, FSR, IBs, periodic safety reports, DDPS, RMPs, CCSI, etc.)
Maintain the service provider updated on the relevant documents needed to perform the contracted activities (IBs, protocols, lists of participating centres, etc.)
Assistance with SAE reconciliation.
Act as main contact liaison between the PV service provider, the CRO, project managers, medical and other functions as necessary.
Maintenance of Safety archive, which include: vendor contracts, project safety plan, SAE forms and instructions, Regulatory documentation: ASR, 6-Month line listings, SUSARs, Regulatory requirements, SAE listings for each project, ARGUS Documentation and Eudravigilance documentation
Prepare and review SOPs.

REQUIREMENTS
You have a degree in a biological science with at least 4 years (bio)pharmaceutical experience in pre- and post-authorisation pharmacovigilance including knowledge of pharmacovigilance regulations and guidelines.
You are familiar with Quality aspects related to PV.
You are fluent in English, both verbal and written (capable of writing clearly and accurately). Knowledge of other languages will be a plus.
You show initiative, proactiveness and a quality-driven approach to work, and team spirit.
You have good interpersonal, communication and organization skills.
You are PC literate; knowledge of any PV software system (ARGUS, ARISg) would be an advantage.
Arbeitsverhältnis
Festanstellung
Befristung
Das Beschäftigungsverhältnis ist unbefristet.
Arbeitszeit
Vollzeit
Vergütungsart
monatliches Festgehalt
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Voraussetzungen für Bewerber
Erforderlicher Bildungsabschluss
kein Abschluss
Erwartete Berufserfahrung
Keine Erfahrung erforderlich
Erforderliche Sprachkenntnisse
Deutsch (Fortgeschritten)
Englisch (Fortgeschritten)
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Arbeitsort
Land
Deutschland
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Statistik für diese Gigajob-Anzeige (133.882.764)
Kurz-Link: https://de.gigajob.com/133882764.html
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