Life Sciences Safety Systems
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Life Sciences Safety Systems Specialist Job at IQVIA

Life Sciences Safety Systems Specialist Job at IQVIA, Apply Online. BSc Life sciences (Senior) Safety Systems Specialist – IQVIA Biotech India (Homebased) jobs at IQVIA. Interested and eligible applicants can check out all of the details on the same below

Name of the Post – (Senior) Safety Systems Specialist – IQVIA Biotech India (Homebased)

Primary Location – Bangalore, India

Full time

Job ID – R1238557

BASIC FUNCTION:

Responsible for the configuration and ongoing maintenance of the Argus Safety System and associated modules; serves as primary technical support for troubleshooting functionality issues within application and provides technical advice related to troubleshooting and other system requests

Delivers Safety Management Department services according to ICH-GCP guidelines, regulatory requirements and IQVIA Biotech SOPs and/or project-specific procedures.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Responsible for the configuration and maintenance of Oracle Argus Safety System including:
    • Enterprise creation
    • User maintenance
    • Study design
    • E2B exporting and importing
    • Aggregate Reporting
    • Expedited Reporting
    • Periodic Reporting
  • Liaises with IT and Safety to facilitate timely resolution of system requests
  • Develops and maintains reports related to Safety; provides regular updates to Safety team members on the status of reporting activities
  • Creates and executes system validation
  • Leads internal and client calls when Safety technical support is required; communicates technical information clearly and concisely to non-technical individuals
  • Prepares safety reports for submission to Sponsors, Regulatory Authorities or Investigators
  • Performs project related study close-out and archival tasks
  • Assists management and/or Safety Management Lead in writing Standard Operating Procedures and developing documents related to intake/triage functions, including study-specific processes
  • Assists management in defining and implementing process improvement activities to increase efficiency within the Safety Management Department.
  • Mentors and/or trains new Safety staff
  • Performs other duties as assigned by the manager.
  • Maintains and further develop Content Management System (CMS)

KNOWLEDGE, SKILLS AND ABILITIES:

  • Ability to lead study configuration approaches within the Safety Database to produce desirable outputs at all stages of the study.
  • Ability to read and write PL/SQL
  • Excellent written and verbal communication skills.
  • Positive attitude and proactive approach to interacting with all levels of staff and clients to successfully coordinate and execute Safety Management department activities.
  • Excellent organization skills and ability to handle multiple priorities while adhering to applicable timelines.
  • Ability to work independently, develop and follow instructions/guidelines and demonstrate initiative.
  • Basic knowledge of medical terminology.
  • Good knowledge of the clinical research process and current GCP/ICH guidelines applicable to the conduct of clinical research.
  • Establishes and maintains effective relationships with customers (internal and external Provides customers with complete and accurate information. Maintains a high energy level when interacting with customers. Acts with the customer in mind.
  • Ability to research and troubleshoot issues independently
  • Ability to work within a matrix team environment required.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

  • Very limited physical effort required to perform normal job duties

MINIMUM RECRUITMENT STANDARDS:

  • Bachelor’s Degree, life science or clinical research preferred, plus 3 years of Oracle Argus Safety and pharmacovigilance processing; or, an equivalent level of education and experience
  • Advanced Computer literacy and experience of working with Microsoft Office (Word, Excel) required.
  • Understanding of Networking and computer languages including Oracle PL/SQL and Visual Basic
  • Ability to work directly within Oracle and MySQL Databases
  • Excellent written and verbal communication skills are required.
  • Good interpersonal and organization skills are required.

CLASSIFICATION (US):

This position is classified as exempt; employees are not eligible for overtime compensation.

APPLY ONLINE

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