Job Title: Senior Safety Systems Specialist
Location: Bangalore, India
Category: Clinical
Job ID: 254873
The Senior Safety Systems Specialist is responsible for implementing, supporting, configuring, and migrating safety systems. The role ensures high-quality, cost-effective service delivery to internal and external clients, complying with applicable health and safety regulations and organizational standards.
System Configuration & Support
Conduct project-specific configurations in drug safety systems (e.g., Argus, ARISg, Veeva, or equivalent).
Maintain and document system configurations based on initial requirements and subsequent changes.
Develop standard and ad hoc reports from safety systems.
Support and educate end-users and sponsors as required.
Collaborate with training teams to develop safety system-specific training modules.
Business Analysis & Reporting
Engage with business stakeholders to understand and document requirements, ensuring timely delivery in collaboration with technical partners.
Provide guidance on front-end reporting using advanced conditions and Standard MedDRA Queries (SMQs).
Conduct routine and ad hoc data extractions (e.g., PSURs, DSURs, 6-monthly listings).
Data Migration & Change Management
Actively participate in data migration activities and related documentation.
Support system change management, updates to SOPs, working practices, and guidelines.
Perform User Acceptance Testing (UAT) and complete associated documentation.
Issue Management & Quality Assurance
Act as subject matter expert to identify improvements in compliance, quality, and efficiency.
Manage ticketing, issue resolution, and escalation of system issues when necessary.
Respond to mailbox queries and complete work assignments according to SOPs and PV regulations.
Other Duties
Perform additional tasks assigned by management.
Maintain compliance with Health and Safety at Work Act 1974, COSHH regulations 1989, and EC Directives 1992/3.
Minimum Required
Degree in Life Sciences or IT/Computing (relevant experience may substitute for educational requirements).
At least 3 years of experience with drug safety systems (e.g., Argus, ARISg, Veeva, or equivalent).
Good working knowledge of Microsoft Office tools and system integration.
Preferred Qualifications
Clinical background with experience working on clinical systems.
Knowledge of SQL programming.
Strong team player with peer support capability.
Ability to prioritize tasks and manage multiple assignments.
Attention to detail, logical thinking, and strong proofreading skills.
Good written and verbal communication skills.
Experience in systems operations support and validated document management.
Familiarity with MS Office and standard office equipment.
Office-based or remote work.
Drug Safety Systems
Pharmacovigilance Systems
PV Data Management
System Configuration & Support
Safety Reporting & Compliance
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