Case Analysis & Data Entry along with Mailbox-handling & Submission activities.
Function To carry out pre-intake (out of database) activity. This includes safety mailbox handling and assessment of source documents for MFR receipt date, validity and country or region etc.Management PV mailbox and follow-up communication as appropriatePerform screening and assessment of Eudravigilance Web portalReviews full source document(s), decide on case validity and trigger requests for additional data or request of clarification,Assess seriousness of the case & accordingly prioritizePerforms duplicate check, register case & attach source document(s) in client’ patient safety applicationAccurate and timely case management of serious and non-serious adverse events into patient safety application according to User Manual, SOPs and relevant data entry instructionsCreation of comprehensive case descriptions (narratives) in English language extracting relevant PV information from routine source documentsTransmission to DSUs of emails of complete cases/docs not to be inserted in client safety application (if needed)Timely completion of cases routed back from the Drug Safety Scientist/ Drug Safety Physician for correctionInitiate follow-up activities to obtain additional information and clarification, as appropriateForward cases for quality review or invalid workflow, as applicable, in the patient safety applicationPerform reconciliation, and document and track compliance related data
- Bachelors/Masters in Pharmacy or Graduate/Post Graduate in Life Sciences or Alternate Medicine, Biomedical Degree or Nursing etc.
- Fluent in English
- Basic competence with medical and therapeutic terminology
- Able to work independently, guided by procedures, with appropriate support
- Good time management and prioritisation
- Attention to detail
- Prior relevant experice in Life Sciences or Health Care industry
- Prior Experience in pharmacovigilance
For more information, please contact Fanni Zsigri on: +36 30 160 5236
For more information please contact Fanni Zsigri on: +36 30 160 5236