Recruitment in Novartis for the post of Pharmacovigilance Expert
Job Description
Provide support to the IMS Department in the single case medical review and associated activities as needed such as Periodic Safety Update Report (PSUR), coordinating the management of large datasets for analysis purposes, responses to Health Authorities, within agreed timeframes and to a high standard of accuracy, in compliance with DS&E business rules, standard operating proce-dures and global and local regulatory requirements.
1. Performs single case medical review in the safety database or on line listings Of Oncology marketed products.
2. Author or co-authors the medical sections of PSURs including literature review and analysis of known and potential risks defined in the RMP.
3. Assists in the preparation of other safety documents, as needed/required, including Annual Safety Update Reports (ASR), DSURs, Core Data Sheets (CDS) and IBs.
Provide support to the IMS Department in the single case medical review and associated activities as needed such as Periodic Safety Update Report (PSUR), coordinating the management of large datasets for analysis purposes, responses to Health Authorities, within agreed timeframes and to a high standard of accuracy, in compliance with DS&E business rules, standard operating proce-dures and global and local regulatory requirements.
1. Performs single case medical review in the safety database or on line listings Of Oncology marketed products.
2. Author or co-authors the medical sections of PSURs including literature review and analysis of known and potential risks defined in the RMP.
3. Assists in the preparation of other safety documents, as needed/required, including Annual Safety Update Reports (ASR), DSURs, Core Data Sheets (CDS) and IBs.
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