Pharmacovigilance & Medical Specialist
6 mesi fa
Zentiva è un’azienda farmaceutica specializzata nella produzione di medicinali di alta qualità a prezzi accessibili. Con un team globale composto da 5.000 persone e una rete di siti di produzione a Praga, Bucarest e Ankleshwar, Zentiva è leader nel campo dei farmaci generici e delle specialità medicinali in Europa, supportando al meglio le esigenze sanitarie quotidiane delle persone.
Zentiva Italia è un'azienda in forte espansione, che può offrire un'intensa esperienza di crescita professionale in un contesto giovane, dinamico e con una chiara e forte visione di sviluppo strategico e commerciale.
Per la nostra sede di Milano stiamo cercando un/a Pharmacovigilance & Medical Specialist che, all'interno del team di Scientific Affairs, si occuperà di:
- Gestione del sistema locale di farmacovigilanza e medical information, in sinergia con le altre funzioni del dipartimento di Scientific Affairs e le funzioni Corporate;
- Local Literature Screening per tutto il portfolio prodotti;
- Gestione e partecipazione a Audit e ispezioni da parte di Corporate o organismi esterni;
- Revisione ed aggiornamento delle procedure relative all’area medical affairs e farmacovigilanza;
- Monitoraggio dei siti istituzionali locali/europei per quanto concerne le informazioni di sicurezza ed eventuali nuovi requisiti normativi;
- Supporto alla preparazione di PSUR/PBRER;
- Gestione locale dell’implementazione delle misure di minimizzazione del rischio (DHPC, Materiali educazioni e aRMMs);
- Preparazione e distribuzione delle note informative interne sugli aggiornamenti del profilo di sicurezza dei prodotti;
- Monitoraggio dei KPI locali e dell’efficienza del sistema di farmacovigilanza locale;
- Gestione della formazione in ambito farmacovigilanza;
- Gestione dei servizi di informazione medico scientifica;
- Supporto al Servizio Scientifico.
- Laurea in discipline scientifiche;
- 3-5 anni di esperienza in ruoli di farmacovigilanza o di medical affairs;
- Provenienza da un contesto consulenziale o aziendale in ambito farmaceutico;
- Ottima conoscenza orale e scritta della lingua Inglese;
- Capacità analitiche, Precisione, capacità di lavorare in team.
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