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5.0 - 7.0 years
0 Lacs
bengaluru, karnataka, india
On-site
Purpose And Scope Support the development, implementation, and successful execution of the Medical Assurance objectives, supporting the overall PV Case Management, RAPV Operations and RAPV mission. Contribute to driving a globally aligned approach to ensure ICSR medico-scientific quality and consistency, to support the effective management of the safety profile of Astellas marketed and investigational products. Collaborate with vendor medical personnel, Astellas RAPV and non-RAPV colleagues to ensure, support and improve processes to deliver high quality medico-scientific assessments for ICSRs. Maintain processes and tools to support high quality medico-scientific assessment of ICSRs Lead pr...
Posted 1 day ago
6.0 - 10.0 years
0 Lacs
pune, maharashtra
On-site
Role Overview: You will be responsible for Pharmacovigilance data entry tasks, specifically catering to N1 Japanese bilingual requirements. With 6 to 8 years of relevant experience, your expertise in Pharmacovigilance data entry will be crucial for this position. You should be capable of understanding source documents, assessing safety information for ICSR cases, coding verbatim events using MedDRA dictionary, and determining the seriousness, listedness, and causal relationship of events. Additionally, you will be expected to interpret source documents from a medical perspective and provide narrative descriptions chronologically. Your role will also involve quality management tasks such as p...
Posted 1 week ago
6.0 - 10.0 years
0 Lacs
pune, maharashtra
On-site
You will be responsible for N1 Japanese bilingual + Pharmacovigilance related tasks with 6 to 8 years of relevant experience. Your primary expertise should lie in Pharmacovigilance data entry, including the ability to interpret source documents, assess safety information for ICSR cases, code verbatim events using the MedDRA dictionary, and evaluate seriousness, listedness, and causal relationships of events. You should have the capability to analyze source documents from a medical perspective and present the narrative chronologically. Quality management is a key aspect of this role, involving the retrospective review of ICSR source documents and data entries, ensuring accuracy in MedDRA and ...
Posted 2 months ago
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