
Regulatory & Pharmacovigilance Specialist
6 hours ago
Om tjänsten
Du kommer att vara ansvarig för regulatoriska frågor samt farmakovigilans och rollen innebär en kombination av operativa uppgifter samt att säkerställa övergripande tillsyn och koordinering av aktiviteter inom ansvarsområdet. Det kommer att vara ett nära samarbete med andra funktioner såsom kommersiella, medicinska och supply chain-avdelningar, samt regulatoriska- och farmakovigilans-team på företagets huvudkontor. Rollen är placerad i Stockholm och rapporterar till Head of Pharmaceutical Affairs.
Dina arbetsuppgifter i huvudsak
• Regulatoriskt ansvar för viss affärsenhet, inklusive lanseringsplanering
• Driva lokala regulatoriska aktiviteter i linje med affärens prioriteringar
• Lokala regulatoriska inlämningar, översättningskoordination och uppdatering av artwork
• Lokalt kontaktansvar gentemot nordiska regulatoriska myndigheter
• Ge regulatorisk expertis till andra lokala funktioner såsom marknadsföring, value & access samt supply chain
• Koordinering och lokala inlämningar av aRMM
• Farmakovigilans-input i medicinska och marknadsföringsprojekt
• Hantering av SDEA och genomförande av PV-granskning av allmänna avtal
• Hantering av ICSRs, inklusive kodning enligt MEDDRA
Vem är du?
• Högskoleexamen inom Life Science, farmaci eller motsvarande
• Minst 1-2 års erfarenhet inom farmakovigilansområdet
• Minst 2-3 års erfarenhet inom Regulatory Affairs, gärna inom ett nordiskt marknadsbolag.
• Flytande i både tal och skrift på engelska samt ett nordiskt språk
Om du är en självgående och lösningsorienterad person som vill arbeta i en dynamisk och internationell miljö ser vi fram emot att ta emot din ansökan
Om verksamheten
QRIOS Life Science är ett ledande konsultföretag som specialiserar sig på att leverera högkvalitativa lösningar och expertis inom Life Science-sektorn. Vi arbetar nära våra kunder för att förstå deras unika behov och leverera skräddarsydda lösningar som driver innovation och framgång. Med ett starkt fokus på kvalitet och engagemang strävar vi efter att vara den främsta partnern inom vår bransch. Vi är ett konsultföretag som inte är som många andra, inspirerade av de som aldrig slutar leta efter nya lösningar. Som vi säger, QRIOS MINDS GÅR LÄNGRE
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