Farmaceutische Industrie: Vigilance and Regulatory

Il y a 6 mois


Gent, Belgique Studio Pharma Temps plein

Voor ons klein maar supersympathiek team zijn we op zoek naar een nieuwe medewerker met een passie voor en interesse in farmaceutische wetgeving en vigilantie. Je helpt mee nieuwe geneesmiddelen en voedingssupplementen te registreren, hun marketing materiaal te bekijken en goed te keuren, en hun veiligheid te bewaken (farmacovigilantie), en dit voor Benelux en EU bedrijven. Een heel gevarieerde job

Idealiter heb je nog niet zo lang geleden de schoolbanken verlaten en ben je op zoek naar een gevarieerde job in de farmaceutische industrie. Je hebt een diploma farmaceutische wetenschappen (apotheker) of biomedische wetenschappen.

Je komt terecht in een dynamisch team, een mix van junior en meer ervaren collega's, die ernaar uitkijken jou veel te leren

We werken in een internationale omgeving waar veel engels (en ook frans) wordt gesproken en geschreven.

**Over Studio Pharma**:
Studio Pharma is een klein maar flexibel consultancybedrijf dat diensten aanbiedt aan de Europese farmaceutische industrie. Onze kantoren bevinden zich in de buurt van de prachtige oude stad van Gent.

Het Studio Pharma team heeft veel ervaring in verschillende domeinen (regelgeving, kwaliteit, vigilantie) en in verschillende productcategorieën (geneesmiddelen, voedingssupplementen, medische hulpmiddelen en cosmetica).

**Over de functie**:
Als RA/Vigilantie Officer kom je terecht in een klein team waarin de balans tussen werk en privé en een prettige en ondersteunende werkomgeving heel belangrijk is.

Je ondersteunt bij een divers scala aan projecten:

- Lokale farmacovigilantie activiteiten (adverse event handling, reconciliatie, literatuurscreening, medische vragen...)
- Deelnemen aan audits en vigilantie inspecties
- Opvolgen van regulatory intelligence en vigilantie-updates
- Compliance activiteiten (transparantie, Mdeon visumaanvragen, controle van promotiemateriaal...)
- Indienen en opvolgen van aanvragen en variaties voor geneesmiddelen
- Nationale BeNeLux-procedures: notificaties, CPP's (Certificaten van Farmaceutische Producten)
- Bijhouden van trackers voor regelgevende informatie
- Updates van geneesmiddeleninformatie (SKP, Bijsluiter, Etikettering, Artwork)
- Communicatie met lokale bevoegde instanties en Europese klanten

**Jouw profiel**:
We zijn op zoek naar een gemotiveerde en enthousiaste collega met een farmaceutische achtergrond (apotheker bij voorkeur), die beschikbaar is om zo snel mogelijk te starten, een open en ondernemende ingesteldheid heeft, met een goede kennis van het Engels en het Nederlands en indien mogelijk het Frans. Punctualiteit en kennis van Microsoft office tools zijn een basisvereiste.

Junior profielen met motivatie zijn ook welkom om te solliciteren

Deeltijds werken behoort tot de mogelijkheden.

We kijken ernaar uit je te ontmoeten

Dienstverband: Voltijds, Onbepaalde duur

Loon: €3.000,00 - €3.500,00 per maand

Werklocatie: Hybride telewerken in 9050 Gent



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