Good understanding about ISO IDMP standards, EMA SPOR Data and IDMP requirements.
Good knowledge on , xEVMPD controlled vocabularies, Data Entry Tool (EVWEB) user manual, EMA registration process, MedDRA coding, EMA account management portal, Organisations management services (OMS) and SPOR master data.
Knowledge on IDMP standards for the interpretation of entire product lifecycle: products in development, investigational products, products under evaluation and authorized products.
Ensured accurate data cleansing and enrichment for CPs in PMS PUI, handled OMS,RMS and SMS requests within the SPOR database and performed data cleanup activities related to ISO IDMP and SPOR.
Job Classification
Industry: Analytics / KPO / ResearchFunctional Area / Department: Engineering - Software & QARole Category: Software DevelopmentRole: Technical LeadEmployement Type: Full time