Alle Pharmacovigilance Manager - Jobs in Deutschland
Alle Pharmacovigilance Manager - Jobs
Alle Jobs in Deutschland
Pharmacovigilance Manager, Drug Safety, Pharma & BiotechArbeitsort: Deutschland
- SIRE Life Sciences
- monatliches Festgehalt
- Anzeige vom:
- 10.12.2014 (835 Tage alt)
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:
Clinical Research Organisations
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”
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.
Pharmacovigilance Manager, Drug Safety, Pharma & Biotech.
For various Biotechnology and Pharmaceutical clients in Germany we are looking for Pharmacovigilance / Drug Safety professionals.
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.
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.