Cloud engineer állások XXIII. kerületben (egészségügy, gyógyszeripar)

• You will ensure the end-to-end collection and reporting of safety information in strict compliance with Roche and local regulatory requirements.
• You will maintain robust oversight of safety risk management activities, including those executed by our external partners and vendors.

• Stratégiai tervezés: Számítógépes kémiai megközelítések kidolgozása a gyógyszerkutatási portfólió támogatására.
• Célpont-értékelés: Új biológiai célpontok vizsgálata (szekvencia-illesztés, 3D modellezés: homológia, AlphaFold), biológiai és szabadalmi források kutatása.

• AI Agent-ek fejlesztése Copilot Studio-ban
• AI és Data Science projektek támogatása
• Adatelőkészítési és adatfeldolgozási feladatok ellátása
• Új AI technológiák és megoldások kutatása
• Prototípusok és MVP-k fejlesztésének támogatása
• Dokumentációk készítése és eredmények prezentálása

• Utilize clinical information in safety database to provide company causality assessment and comment.
• Review case reports for medical accuracy, including validation of adverse event listedness and coding consistency.
• Request follow-up information for robust case causality assessment.

• Receipt / Download / Accepting of cases from Document Exchange Tool or electronically (or any other source)
• Translation of all relevant European Non-English information from source documents to English (if required) and updating relevant fields in Standard Adverse Event (AE) form

• Receipt / Download / Accept cases from Document Exchange Tool or electronically (or any other source)
• Translation of all relevant European Non-English information from source documents to English (if required) and updating relevant fields in Standard Adverse Event (AE) form

• Acquiring and maintaining marketing authorizations.
• Creating the necessary submissions for authorizations and tracking them from the first documentation until authority decision.
• Monitoring relevant legal changes and verifying the accuracy of packaging materials and patient information leaflets.

• Receipt / Download / Accepting of cases from Document Exchange Tool or electronically (or any other source)
• Translation of all relevant European Non-English information from source documents to English (if required) and updating relevant fields in Standard Adverse Event (AE) form

• Receipt / Download / Accepting of cases from Document Exchange Tool or electronically (or any other source)
• Translation of all relevant European Non-English information from source documents to English (if required) and updating relevant fields in Standard Adverse Event (AE) form

Monitors CSR’s performance on a daily basis, by taping, listening to, reviewing and evaluating calls...

• Lifecycle management of approved regulatory files
• Documentation support in registration and renewal procedures
• Preparation of ASMF/DMF/CEP according to project timelines, ensuring compliance with regulatory requirements and facilitating submissions to the Authorities

Working directly with customers and project teams providing technical expertise on Veeva’s applications, Vault Platform, APIs, and Java SDK Developing custom code and configuring Veeva software Contributing to solution design under guidance of experienced technical and migration architects...

Implementation of new features within the Veeva Quality suite at Life Sciences companies Solutioning and configuration of Vault applications to meet customer needs, including workflows, document types, security, fields, page layouts, notifications Collaboration with customer's business and IT staff...

Implementation of new features within the Veeva Quality suite at Life Sciences companies Guidance on enhancing quality and compliance culture through Veeva Quality suite Design of customer-requested and proactive solutions Customer liaison and communication management between implementation,...

Lifecycle validation of computer systems Development of validation frameworks Management of risk-based testing strategies Ensuring IT systems fit for intended use and maintain data integrity Development and maintenance of the Validation Master Plan (VMP) Definition of validation scope using...