Ofertes d'ocupació a Novartis

• Nivell d'experiència---
• Tipus de contracteA temps complert
• PublicadaNova

. QA

Summary

Step into a critical quality role where your expertise ensures the safety and integrity of global healthcare. As the Manager, Pharmacovigilance QA, you’ll provide end-to-end quality assurance oversight for Pharmacovigilance (PV) and Device Vigilance (DV) activities across Novartis. You’ll be instrumental in maintaining compliance with both local and global regulatory standards, while upholding Novartis’ commitment to excellence in patient safety. This is a unique opportunity to influence quality systems, support innovation, and make a meaningful impact on global health outcomes.

#Hybrid

Location: Barcelona, Spain or Hyderabad, India

About The Role

Key Responsibilities:

• Support initiatives to maintain or improve quality performance and compliance of Novartis PV activities including case processing, medical safety, risk management, Health Authority reporting, PV IT systems and device vigilance. Champion the quality mindset.
• Support initiatives focused on quality, process, and compliance improvement. Through close collaboration with business partners, identify opportunities and develop strategies aimed at simplifying processes and improving quality while ensuring compliance with applicable regulatory requirements.
• Provide quality support of transition and integration-related activities for PV and Device Vigilance systems resulting from mergers, acquisitions, and/or divestments.
• Support maintenance of the Pharmacovigilance System Master File (PSMF).
• Support training initiatives as assigned.
• Provide quality support to PS&PV and other groups/business partners involved in PV and DV activities; assist with issue identification and root cause investigations; sign-off investigation reports.
• Support Health Authority Inspections, including inspection readiness activities, conduct, and follow-up.
• Guide the development of robust and sustainable corrective and preventative action plans (CAPA) in collaboration with the responsible groups performing PV and DV activities. Monitor status of corrective and preventative actions to ensure the issues are adequately addressed, completed, and appropriately documented.
• Ensure quality and regulatory compliance issues are promptly communicated to appropriate management. Support initiatives geared towards remediation of compliance concerns; determine effectiveness of remediation activities; provide ongoing project support and governance.
• Support activities to ensure effective quality oversight, management, and support of global PV operational vendors. Support vendor quality awareness and improvement measures.
  
  

• Relevant Degree in Life Sciences or related scientific discipline; higher degree desirable.
• Proficiency in English required – spoken & written, other languages is an asset.
• Demonstrated PV/PV quality and related pharmaceutical industry and/or Health Authority experience; Device vigilance experience a plus.
• PV auditing or inspection experience and Health Authority interactions a plus.
• Experience in maintenance of PV and/or device Quality Management Systems a plus.
• Ability to manage and objectively evaluate compliance issues with limited supervision; good problem solving, decision making and prioritization skills.
• Quality mindset.
• Good knowledge of PV regulations, guidelines, and policies; awareness of GCP and Part 11 requirements a plus.
• Ability to operate cross-functionally and in diverse cultural environments.
  
  

• Nivell d'experiència---
• Tipus de contracteA temps complert
• Publicada19 de nov.

.

Summary

Мониторинг данных о пациентах и информации, связанной с исследованием, связанной с клиническими исследованиями и участием в клинических испытаниях. Обеспечивает соблюдение следователем протоколов исследований, нормативных требований и передовой клинической практики и обеспечивает ввод в план проверки данных. Обеспечивает своевременный и точный мониторинг данных пациентов и информации, связанной с исследованием, из исходных документов, научных записей и посещений объектов, где это применимо. Может следить за местами проведения исследований и отбора аудиторских объектов.

About The Role

Major Accountabilities

~ Отбирает потенциальные центры для участия в клиническом исследовании для оценки их возможностей.

~ Проводит инициирующий визит и полную подготовку персонала центра по всем аспектам исследования

~ Применяет политики и процедуры компании для устранения различных проблем

~ Осуществляет частые внутренние и внешние контакты. Представляет организацию в определённых проектах

~ Участвует в выполнении некоторых целей и задач центра расходов

~ Является основным контактным лицом между Novartis и центрами, обеспечивающим эффективное сотрудничество, привлечение центров и соответствие ожиданиям Novartis по срокам и результатам.

~ Сообщение о технических жалобах / неблагоприятных событиях / сценариях особых случаев, связанных с продуктами Novartis в течение 24 часов с момента получения

~ Распространение маркетинговых образцов (если применимо)

Key Performance Indicators

Мониторинг данных о пациентах и информации, связанной с исследованием, связанной с клиническими исследованиями и участием в клинических испытаниях. Обеспечивает соблюдение следователем протоколов исследований, нормативных требований и передовой клинической практики и обеспечивает ввод в план проверки данных. Обеспечивает своевременный и точный мониторинг данных пациентов и информации, связанной с исследованием, из исходных документов, научных записей и посещений объектов, где это применимо. Может следить за местами проведения исследований и отбора аудиторских объектов.

Work Experience

~Руководство операционными процессами и их осуществление

~Управление проектами

~Представление организации

Skills

~Клинический мониторинг

~Клинические исследования

~Системы управления клиническими исследованиями

~Клинические исследования

~Сотрудничество

~Целостность данных

~Медико-биологические науки

~Отчеты о клинических исследованиях

~Навыки принятия решений

Language

Английский

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

• Nivell d'experiència---
• Tipus de contracteA temps complert
• Publicada19 de nov.

.

Summary

Spremlja podatke o bolnikih in informacije, povezane s študijami, povezane s kliničnimi študijami in udeležbo v kliničnih preskušanjih.. Zagotavlja, da raziskovalec upošteva raziskovalne protokole, regulativne zahteve in dobre klinične prakse ter zagotavlja vnos v načrt za potrjevanje podatkov. Zagotavlja pravočasno in natančno spremljanje podatkov o bolnikih in informacij, povezanih s študijo, iz izvornih dokumentov, raziskovalnih evidenc in obiskov na kraju samem, kjer je to primerno. Lahko spremlja študijska mesta in izbor revizijskih ustanov.

About The Role

Major Accountabilities

~ Izvede izbiro mesta za morebitna mesta, da oceni njihove zmožnosti za izvajanje kliničnega preskušanja

~ Izvede začetek obiska mesta, zagotavlja, da je osebje mesta v celoti usposobljeno za vse vidike, povezane s preskušanjem

~ Uporabi pravilnike in postopke podjetja za reševanje različnih težav

~ Pogosta notranja družba in zunanji stiki. Zastopa organizacijo za določene projekte

~ Prispeva k nekaterim stroškom center ciljev in ciljev

~ Je Frontline povezava med Novartis in območij, da se zagotovi uspešno sodelovanje, spletno stran udejstvovanje in srečanje Novartis pričakovanja o mejnik in dostave

~ Poročanje o tehničnih pritožbah / neželenih dogodkih / scenarijih posebnih primerov, povezanih z Novartis izdelki v roku 24 ur po prejemu

~ Distribucija vzorcev trženja (kjer je primerno)

Key Performance Indicators

Spremlja podatke o bolnikih in informacije, povezane s študijami, povezane s kliničnimi študijami in udeležbo v kliničnih preskušanjih.. Zagotavlja, da raziskovalec upošteva raziskovalne protokole, regulativne zahteve in dobre klinične prakse ter zagotavlja vnos v načrt za potrjevanje podatkov. Zagotavlja pravočasno in natančno spremljanje podatkov o bolnikih in informacij, povezanih s študijo, iz izvornih dokumentov, raziskovalnih evidenc in obiskov na kraju samem, kjer je to primerno. Lahko spremlja študijska mesta in izbor revizijskih ustanov.

Work Experience

~Vodenje operacij in izvrševanje

~Vodenje projektov

~Zastopanje organizacije

Skills

~Klinično spremljanje

~Klinične raziskave

~Sistemi vodenja kliničnih preskušanj

~Klinično preskušanje

~Sodelovanje

~Celovitost podatkov

~Vede o življenju

~Poročila o kliničnih študijah

~Sposobnosti odločanja

Language

Angleščina

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

• Nivell d'experiència---
• Tipus de contracteA temps complert
• Publicada19 de nov.

.

Summary

Monitora i dati dei pazienti e le informazioni relative allo studio relative ai siti di studio clinico e alla partecipazione agli studi clinici.. Assicura che il ricercatore aderisca ai protocolli di ricerca, ai requisiti normativi e alle buone pratiche cliniche e fornisce input nel piano di convalida dei dati. Fornisce un monitoraggio tempestivo e accurato dei dati dei pazienti e delle informazioni relative allo studio da documenti di origine, registri di ricerca e visite in loco, ove applicabile. Può monitorare i siti di studio e la selezione delle strutture di audit.

About The Role

Major Accountabilities

~ Conduce la selezione dei siti potenziali per valutare le loro capacità di condurre una sperimentazione clinica

~ Esegue la visita di avvio del sito, assicura il personale sia completamente addestrato sugli aspetti relativi alla prova

~ Applica le politiche e le procedure aziendali per risolvere una varietà di problemi

~ Azienda interna frequente e contatti esterni.

~ Rappresenta l'organizzazione in progetti specifici

~ Contribuisce ad obiettivi e obiettivi del centro di costo

~ Segnalazione di reclami tecnici / eventi avversi / scenari di casi speciali relativi ai prodotti Novartis entro 24 ore dal ricevimento

~ Distribuzione di campioni di marketing (se del caso)

Key Performance Indicators

Monitora i dati dei pazienti e le informazioni relative allo studio relative ai siti di studio clinico e alla partecipazione agli studi clinici.. Assicura che il ricercatore aderisca ai protocolli di ricerca, ai requisiti normativi e alle buone pratiche cliniche e fornisce input nel piano di convalida dei dati. Fornisce un monitoraggio tempestivo e accurato dei dati dei pazienti e delle informazioni relative allo studio da documenti di origine, registri di ricerca e visite in loco, ove applicabile. Può monitorare i siti di studio e la selezione delle strutture di audit.

Work Experience

~Operations management and execution

~Project Management

~Rappresentare l’azienda

Skills

~Monitoraggio clinico

~Ricerca Clinica

~Sistemi di gestione delle sperimentazioni cliniche

~Clinici

~Collaborazione

~Integrità dei dati

~Scienze biologiche

~Rapporti di studi clinici

~Capacità decisionali

Language

Inglese

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards