Senior Safety Systems Specialist
Location: Bangalore
Category: Clinical
Job ID: 254873
Job Overview
The Senior Safety Systems Specialist will assist with the implementation, support, configuration, and migration of safety systems. The role involves providing high-quality service to clients, either as a support function to project groups or as a standalone business. The candidate is expected to comply with legal requirements including the Health and Safety at Work Act 1974, COSHH regulations 1989, and EC Directives 1992/3, as outlined in the company’s Health and Safety Manual.
Qualifications (Minimum Required)
Degree in Life Sciences or IT/Computing.
Relevant and equivalent experience may be considered in lieu of a degree.
Minimum 3 years of experience with drug safety systems such as Argus, ARISg, Veeva, or equivalents.
Proficient in Microsoft Office tools.
Knowledge of system integration.
Summary of Responsibilities
Act as a PV systems team member, leveraging business and technical knowledge.
Conduct project-specific configurations in safety systems.
Maintain and document system configurations, including updates.
Develop and document standard and ad hoc reports from safety systems.
Support and educate end users and sponsors as applicable.
Collaborate with the training team to develop safety system-specific modules.
Engage with business stakeholders to understand and document requirements; ensure timely delivery in collaboration with technical partners.
Provide guidance on front-end reporting, including advanced conditions and Standard MedDRA Queries (SMQ).
Conduct routine and ad hoc data extraction (PSURs, DSURs, 6-monthly listings).
Participate in data migration activities and related documentation.
Support change management and training as needed.
Manage tickets, resolve issues, and escalate system issues when necessary.
Update departmental SOPs, working practices, and guidelines.
Serve as a subject matter expert, identifying opportunities to improve compliance, quality, and efficiency.
Respond to mailbox queries.
Ensure work assignments meet quality standards, adhere to SOPs, and comply with PV regulations.
Perform User Acceptance Testing (UAT) and document results.
Carry out any other duties as assigned by management.
Experience (Minimum Required)
Experience in systems operations support.
Experience with validated document management.
Strong keyboard and MS Office skills.
Ability to operate standard office equipment.
Preferred Qualifications
Clinical background with experience in clinical systems.
Knowledge of SQL programming.
Strong team player, able to provide peer support.
Ability to prioritize tasks and manage multiple assignments.
Attention to detail with strong logical, spelling, and proofreading skills.
Excellent written and verbal communication.
Physical Demands / Work Environment
Office environment or remote work
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