- Acts as main point of contact in the Pharmacovigilance Quality team for the audit management tool
- Makes extractions from the audit management tool for inclusion in the Pharmacovigilance System and to prepare metrics on performance
- Performs quality control checks on extracts from audit management tool for associated initiatives (e.g. PV Compliance Dashboard)
- Maintains listings of global health authority inspections for the purpose of renewals
- Supports the execution of the risk based PV audit program through ensuring audit program listings are up to date
- Maintain the departmental mailbox
- Develops and/or updates processes associated with main responsibilities
- Participates in projects within competences
- Bachelor’s degree or higher in a scientific field
- At least two years of experience in the pharmaceutical/biotechnology area including time working in Pharmacovigilance and/or Quality-related areas.
- Experience with Cognos, Master Control’s QAAD and/or Sparta’s TrackWise is preferred.
- Experience with data migrations is preferred
- Familiarity with Pharmacovigilance systems in the pharmaceutical industry and of applicable regulations, computerized system validation, GVP principles, and practice
- Effective verbal and written communication skills
- Functional computer literacy including Excel, SharePoint, Skype, and Windows 10
- High level of personal integrity with a strong commitment to patient welfare and ethical behavior
- Fluent in written and spoken English, additional language skills would be an advantage
- Challenging projects based on your interests and skills
- Personal follow-up and clear, transparent communication both before and after commencement of employment
- Possibility to follow extra training
- Inspiring network events and legendary after work drinks
- Strong network of industry leading clients
- Expertise within IT, Engineering and Life Sciences
- A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees
Bezoek pauwelsconsulting.com voor meer informatie over de vacature Pharmacovigilance Quality Specialist of solliciteer online op de vacature Pharmacovigilance Quality Specialist.
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