LogoFresh Jobs Ahead
ERGOMED
ERGOMED
1.001 – 5.000 Angajați
Asistență medicalăConsultanțăLogistică
ERGOMED este un grup global de servicii medicale care sprijină companiile de biotehnologie și farmaceutice pe parcursul întregului ciclu de dezvoltare a medicamentelor. Activitățile sale includ Ergomed Clinical Research, PrimeVigilance și ADAMAS Consulting, oferind servicii de organizație de cercetare clinică, asistență în farmacovigilență și informații medicale, precum și audituri GxP. Compania lucrează la studii clinice în oncologie, boli rare și alte domenii complexe, având operațiuni în aproximativ 100 de țări.
LinkedIn
Locurile de muncă ale companiei

Safety System Administrator – Argus Safety | ERGOMED | India Remote

Administer and configure Argus Safety databases supporting PrimeVigilance’s global pharmacovigilance operations. The role covers data migration, validation, access management, user training, troubleshooting, compliance reporting, and system improvement.

INIndiaRemoteNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăInginer de date

Descriere

  • Administer safety databases as part of the Safety and Medical Information System Administrator team
  • Support the creation and upgrading of database instances
  • Manage change control and safety data migration activities
  • Provide first-line user support and resolve database issues
  • Maintain shared and project-specific database libraries
  • Contribute to system validation activities
  • Query databases and produce outputs for internal teams and clients
  • Train users and manage database access for internal and client users
  • Configure and maintain products, licenses, studies, and reporting destinations
  • Document and validate changes to project-specific databases
  • Support validation of legacy data transfers
  • Help develop project-specific data-handling guidelines
  • Prepare line listings, tabulations, and database outputs for aggregate reporting, signal detection, reconciliation, and related activities
  • Provide case-processing metrics for invoicing
  • Coordinate, maintain, and revoke user access
  • Maintain database procedures and core data-handling standards
  • Deliver database training and certification to PrimeVigilance users
  • Investigate database-related deviations and document corrective actions
  • Provide quality and compliance metrics to the Quality Team
  • Identify improvement opportunities through training, guideline updates, and user guides
  • Conduct periodic business continuity tests for database failures
  • Assess software defects, user requests, and regulatory changes, then implement and validate appropriate updates
  • Support IT, database vendors, and technical colleagues with troubleshooting and software fixes or enhancements
  • Assist senior management when required
  • May provide chargeable Argus and LSSMV consulting and training to clients

Cerințe

  • Degree-level education
  • Professional experience with Argus Safety Systems
  • Experience configuring Argus Safety Systems
  • Experience with safety data migration
  • Database administration experience
  • Experience creating and upgrading database instances
  • Experience managing change control and data migration activities
  • Experience providing first-line user support and troubleshooting
  • Ability to train users on database systems
  • Ability to perform system validation activities
  • Ability to query databases and generate outputs
  • Knowledge of database libraries, products, licenses, studies, and reporting destinations
  • Ability to prepare line listings, tabulations, and database outputs
  • Ability to manage, maintain, and revoke user access
  • Ability to investigate the root causes of database-related deviations
  • Knowledge of quality procedures and regulatory requirements
  • Ability to conduct business continuity testing for database failures

Beneficii

  • Remote work from India
  • Flexible working environment
  • Professional growth opportunities
  • Supportive, collaborative workplace culture
  • Training and certification opportunities
  • Potential chargeable consulting and training work involving Argus and LSSMV

Locuri de muncă similare

Eli Lilly and Company

Senior Global Regulatory Lead, Neuroscience – Eli Lilly, Indianapolis

Eli Lilly and Company
Asistență medicalăBiotehnologieProduse farmaceutice
USStatele Unite ale Americii
175.500 $ – 257.400 $ / an
La sediuNormă întreagăSeniorLimbă Obligatorie: englezăConformitate

Lead global regulatory strategy for Lilly’s neuroscience medicines throughout development and across their full lifecycle. Oversee FDA submissions and agency engagement while guiding cross-functional regulatory teams.

Deschide
Walmart

Walmart Distinguished Software Engineer, WFS-ICC Atlas Platform

Walmart
B2CComerț cu amănuntulComerț electronic
INIndiaLa sediuNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăInginer full-stackInginer software
CloudMicroserviciiSisteme distribuite

Lead architecture and production engineering for Walmart Fulfillment Services platforms serving millions of sellers. The role focuses on distributed systems and AI-enabled platform capabilities and is based onsite in Bangalore.

Deschide