Вакансия № 18650326 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Понедельник, 5 августа 2024 года.
Дата обновления вакансии № 18650326 на сайте Работа в Москве и Московской области (МО, Подмосковье): Воскресенье, 22 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 18650326 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
-
Receipt, assessment and processing of incoming safety information from multiple sources, both internal and external to the Company;
-
Enter relevant/required safety data into the Global Inbound Receipt System (GIRS) from spontaneous, clinical trials and other solicited sources;
-
Provision of safety information/acknowledgements to marketing partners/other third-party partners/Global Medical Safety within the internal and contractual timelines;
-
Data entry for complex cases (seek support from senior specialist as applicable);
-
Performing follow-up for requesting additional information from multiple sources;
-
Verify and ensure translation of safety information, if applicable;
-
Continual monitoring, assessing the reportability of ICSRs due for regulatory reporting, and submitting to respective Competent Authorities (CAs) / Business Partners (BPs);
-
Enable mechanisms to support LSO oversight;
-
Support timely submission of aggregate safety reports (e.g. DSUR, PSUR etc. applicable) to applicable health authorities, in collaboration with local medical safety input;
-
Ensure accurate and timely documentation of deviations to process/timelines, including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs) as applicable;
-
Support the LSO, in matters pertaining to audit or inspection preparation or conduct.