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Quality Specialist
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Principal Pharmacovigilance Specialist - Søborg, Danmark - Novo Nordisk
Beskrivelse
The positionis placed in the QPPV Office in Global Safety.
Global Safety is globally responsible for handling of adverse events, monitoring product safety, customer complaints and potential recalls in Novo Nordisk.
In QPPV Office we are around 50 colleagues with different professional background divided into different departments ensuring maintenance of PV oversight and compliance and support to the QPPV and deputy QPPV in Novo Nordisk, Global Safety, and affiliates worldwide.
The primary responsibilities of the teams are coordination of PV Audits and Inspections and PV regulatory surveillance and external affairs, tracking of compliance and quality of Individual Case Safety Reports (ICSRs), maintaining Pharmacovigilance System Master File (PSMF), handling Safety Data Exchange Agreements (SDEAs) and integration of new assets, support to HQ functions and affiliates in handling of safety in Patient Support Programs (PSPs)/Market Research Programs (MRPs) and Digital Health initiatives as well as developing & maintaining digital applications for safety data analysis.
Working at Novo Nordisk At Novo Nordisk, we don't wait for change. We drive it.We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessary what will make us successful in the future.
We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them.From research and development, through to manufacturing, marketing, and sales – we're all working to move the needle on patient care.