Safety Technology Analyst
New
J
JobgetherPharmacovigilance, clinical research
Based in IndiaFull-TimeJunior
Salary not disclosed
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Job Details
- Languages
- Fluency in English
- Experience
- At least two years of experience working with pharmacovigilance safety-supporting applications; a minimum of two years of experience collaborating with operational teams
- Required Skills
- SQL
Requirements
- At least two years of experience working with pharmacovigilance safety-supporting applications, including Argus, Vault Safety, EDC systems, Safety ERP platforms, and associated tools.
- At least two years of experience collaborating with operational teams to investigate issues, gather requirements, and deliver technology solutions for safety business processes.
- Demonstrated experience with computerized system validation methodologies and processes in regulated environments.
- Intermediate system administration and application support skills involving pharmacovigilance safety technology.
- Experience with safety databases, gateway and E2B reporting, report development, or signal detection tools.
- Knowledge of 21 CFR Part 11, EMA Annex 11, and GAMP guidelines.
- Intermediate understanding of pharmacovigilance processes, Good Pharmacovigilance Practices (GVP), and Good Clinical Practice (GCP).
- Working knowledge of SQL scripting and technical tools for system administration, data-related tasks, and troubleshooting.
- Familiarity with SDLC processes, change management practices, and Agile methodologies.
- Experience using service desk tools to record, track, investigate, and resolve technical issues.
- Strong technical writing skills and experience preparing documentation and presentations for stakeholders.
- Fluency in English and experience collaborating across multidisciplinary, geographically distributed teams.
- Experience providing peer oversight, coaching, or training to colleagues.
- A bachelor's degree in Engineering, Computer Science, or a related discipline is preferred; a master's degree or equivalent is an advantage.
Responsibilities
- Configure, maintain, and support pharmacovigilance safety databases and associated applications.
- Set up new studies and support periodic and ad hoc report generation, expedited reporting rules, and end-user support.
- Support safety database handovers at the start or closeout of pharmacovigilance operations.
- Develop and update SOPs, technical documentation, and controlled documents.
- Contribute to integrations between safety technology platforms and other applications.
- Collaborate with IT, Quality Assurance, Total Quality Management, auditors, vendors, Safety Services teams, and clients on system administration and technical issues.
- Investigate, document, and resolve technical issues affecting supported systems.
- Support change management, impact assessments, testing, system validation, and software updates under SDLC standards.
- Provide training, guidance, and peer support on safety technology platforms and support procedures.
- Ensure systems and processes comply with applicable pharmaceutical regulations and quality standards, and contribute to continuous improvement.
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