(Senior) Safety Systems Specialist – IQVIA Biotech India (Homebased)
Primary Location: Bangalore, India
IQVIA Biotech is seeking a (Senior) Safety Systems Specialist. Must have experience working in Argus:
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 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 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 interact 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 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, 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 required.
- Good interpersonal and organization skills required.
This position is classified as exempt; employees are not eligible for overtime compensation.