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explore St Julian's , St Julian's
Drug Safety Analyst with Polish open_in_new
explore Prague , Czech Republic
DESCRIPTION
- To process individual case safety reports (ICSR) according to the client relevant global procedure on case intake processes.
- Translation of documents from local language where applicable and verbal follow up on cases.
- Monitoring and triage of incoming reports from various sources
- Review the source documents for validity of ICSR, perform duplicate check in the intake workflow/safety database and confirm whether the information is medically significant or relevant and takes necessary actions in accordance with Client SOPs.
- Performs clear and accurate data capture of cases
- Perform medical coding/Drug Coding for each ICSR in accordance with Client Guidelines and SOPs using MedDRA and WHODD
- Perform submissions in global safety database for all the AEs, SAEs and SUSAR cases to monitor submission related client reports and trouble shoot submission issues if any.
- Perform translations of source document, case narrative, adverse events as applicable.
- Plan and organize work so that SLAs are not missed
- Ensure compliance with Business policies and contractual requirements of Accenture
- Perform internal case quality control to assess and ensure correct information provided
REQUIREMENTS
- Educational and Experience Requirements:
- Speaking and writing skills of Polish language as a local speaker
- Expert at reading and writing in English
- Bachelor’s Degree in Life Sciences
- Self-motivated and enthusiastic
- Adaptable to learn new processes, concepts and skills
- Detail oriented
- Strong oral communication skills
