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Fortrea

Safety Systems Specialist

RemoteIndia only
Published
Role
Operations
Experience
Mid
Salary not disclosed
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No BS summary

Safety systems specialist in Bangalore or remote with 2+ years in drug safety systems such as Argus/ARISg/Veeva. Needs Life Science or IT/computing degree or equivalent experience, systems operations support, validated document management systems, Microsoft Office, and system integration knowledge.

Core skills

Argus/ARISg/Veeva

Required skills

Microsoft Office

Optional skills

SQLticket support applicationsMS OfficeWindows

What you'll do

  • Assist with the overall safety system implementation, support, configuration, and migration related activities.
  • Responsible for providing this service to clients either as a support function to the client project pgroups or as stand- alone business.
  • Responsible for providing all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.
  • Expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual.
  • PV systems team member responsible for leveraging a strong combination of business and technical knowledge.
  • Conduct project specific configurations in Safety systems.
  • Maintain and document system configuration based on initial requirements and any subsequent changes.
  • Develop and document standard and ad hoc reports from the safety systems.
  • Support and educate end users and sponsors, if applicable.
  • Conduct routine and ad hoc data extraction (i.e., PSURs, DSURs, 6-monthly listings).
  • Actively participate in all data migration activities and documentation related to migration.
  • Support with change management and training of the systems, as needed.
  • Support in Ticket management, issue resolution and escalating system issues where applicable.
  • Completing work assignments to the highest quality standards, adhering to relevant SOPs, and keeping up to date with knowledge of current PV regulations.
  • Perform User Acceptance Testing and complete required documentation.
  • Monitor the mailbox for system failures to resolve in a timely manner.
  • Train team members on technical and functional aspects.
  • Respond to mailbox queries.
  • Any other duties as assigned by management.
  • And all other duties as needed or assigned.

What they require

  • Life Science or IT/computing degree.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  • Experience in systems operations support role.
  • Experience working on any validated document management systems.
  • At least 2 years of experience with drug safety systems such as Argus/ARISg/Veeva or equivalent.
  • Good working knowledge of Microsoft office tools.
  • System integration knowledge.
  • Good Team player and offer peer support as needed.
  • Ability to set priorities and handle multiple tasks.
  • Attention to detail.
  • Good written and verbal communication skills.
  • Logical and spelling skills, preferably with an aptitude for handling and proof-reading numerical data.
  • Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
  • Ability to operate standard office equipment.
  • Preferred: Life Science or IT/computing degree.
  • Preferred: Clinical background working with clinical systems.

one of the world´s largest and longest-established early-phase clinical research organizations

HealthcareEnterprisefortrea.com

What people say about this company

2.9/ 5

Salary not disclosed