Senior Safety Technology Analyst
New
J
JobgetherPharmacovigilance technology
Based in IndiaFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- At least five years of hands-on experience with pharmacovigilance safety-supporting applications; a minimum of five years of experience working closely with Safety Operations teams. At least one year of mentoring, training, or peer oversight is desirable.
- Required Skills
- SQL
Requirements
- Have at least five years of hands-on experience with pharmacovigilance safety-supporting applications, including Argus, Vault Safety, EDC systems, and Safety ERP platforms.
- Have at least five years of experience working closely with Safety Operations teams to investigate technical issues, gather business requirements, and deliver technology solutions.
- Demonstrate advanced knowledge of 21 CFR Part 11, EMA Annex 11, and GAMP.
- Be proficient in SQL or other relevant scripting languages.
- Have experience using industry-standard service desk and incident management tools.
- Understand pharmacovigilance processes, GVP, GCP, and applicable safety reporting standards.
- Have experience in system administration, complex configuration, application support, and safety technology platform integration.
- Have practical experience with system validation, change management, testing methodologies, and regulatory-compliant software implementation.
- Have technical writing skills and the ability to explain complex technical concepts to diverse audiences.
- Demonstrate analytical and problem-solving abilities and a client-focused approach.
- Be able to collaborate with stakeholders at different organizational levels and represent the safety technology function in cross-functional discussions.
- Be able to coach, mentor, and guide team members; at least one year of mentoring, training, or peer oversight is desirable.
- Have familiarity with emerging pharmacovigilance technologies, including AI-enabled solutions.
- A bachelor's degree in Engineering, Computer Science, or a related discipline is preferred; a master's degree is an advantage.
- Experience leading or contributing to system and process improvement initiatives, including at least one year of system validation design and execution, is preferred.
Responsibilities
- Configure, implement, administer, and support pharmacovigilance safety databases and associated applications.
- Set up studies and configure periodic, ad hoc, and expedited reporting.
- Manage safety database handovers between clients and the organization at project initiation and completion.
- Design, implement, and maintain integrations between safety technology platforms and other applications.
- Collaborate with IT, Quality Assurance, Safety Operations, and external auditors on regulatory, security, and quality compliance.
- Lead SDLC-based change management, including impact assessments, testing, validation, software updates, and controlled implementation.
- Develop and maintain technical documentation, presentations, SOPs, and controlled documents.
- Coordinate investigation, escalation, and resolution of technical issues with internal teams, vendors, colleagues, and clients.
- Provide technical guidance, training, mentoring, and work direction to team members.
- Evaluate emerging pharmacovigilance technologies, including AI applications, and identify platform and workflow improvements.
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