Pharmacovigilance Manager

Site Name: Italy - VeronaPosted Date: Jun 12 2024We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included.
We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK In this role you will… Supporta il Direttore Medico & Responsabile del Servizio Scientifico nella supervisione dei rischi aziendali di patient safety, inclusa una revisione a livello di RMCB (Risk Management & Compliance Board) locale, in collaborazione con il Named Safety Contact.
Assicura la gestione delle attività di farmacovigilanza in capo alla LOC per i prodotti in commercio e in sviluppo clinico, siano essi Farmaci Etici, Vaccini, garantendo la compliance alle normative di legge locali ed alle Policy/Procedure di Gruppo.
Assume le responsabilità previste in Italia dal ruolo di legge di Responsabile della Farmacovigilanza (FV).
Interagisce con l'AIFA e con i centri regionali di Farmacovigilanza, in relazione ai problemi di human safety ed alle azioni correlate.
Interagisce con il Central Safety Department/Global Regulatory per questioni o richieste provenienti da AIFA sui prodotti GSK, includendo in ciò la gestione delle comunicazioni urgenti di safety quali DIL/DHCP, richieste di informazioni di safety, materiali educazionali etc Interagisce e collabora con le funzioni global, e con il fornitore esterno centrale in caso di necessità, e mantiene l'oversight sulle attività condotte dal fornitore, allo scopo di garantire l'accountability della LOC in materia di farmacovigilanza E' interlocutore delle aziende partner (ViiV) per quanto concerne gli accordi inter-aziendali e l'aggiornamento ai rispettivi GM/funzioni interessate in materia di safety.
Ha conoscenza base: delle normative e leggi di settore oltre a quelle aziendali (Ethical & Legal Compliance) delle norme e dei processi di ricerca clinica, farmacovigilanza, medical information e del processo di sviluppo del farmaco o di un vaccino Why you?
Qualifications& Skills: Laurea in discipleine scientifiche Documentata esperienza & qualifica in materia di farmacoviglianza (D.M.
30 Aprile 2015) Accountabilty for results Communication Skills Networking Project Management Competenza DDA (Digital Data Analytics) e Omnichannel, conoscenza di base di Intelligeza aArtificaiel/Machine Learning Preferred qualifications: Esperienza in ruolo analogo di almeno 3 anni all'interno di Direzione Medica di aziende multinazionali oppure Named Safety Contact per almeno 5 anni.
Capacità di influenzamento Ingelese Fluenete Closing Date for Applications – 5th July Please take a copy of the Job Description, as this will not be available post closure of the advert.When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.
#LI-Hybrid Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive.
We prevent and treat disease with vaccines, specialty and general medicines.
We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people.
While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.
We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be.
A place where they can be themselves – feeling welcome, valued, and included.
Where they can keep growing and look after their wellbeing.
So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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