Job Title: Safety Systems Specialist – Pharmacovigilance
Location: Pune, Maharashtra, India (Remote Work Available)
Employment Type: Full-Time
Experience Required: 7–10 years
Qualification: Bachelor’s in Information Technology or related field
Company Overview:
PrimeVigilance, part of the Ergomed Group, is a leading mid-size pharmacovigilance service provider established in 2008. With global operations spanning Europe, North America, and Asia, we provide specialized support across Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. We partner with pharmaceutical and biotechnology companies to deliver high-quality services across all therapeutic areas, including medical devices.
At PrimeVigilance, we invest in employee development, foster well-being, and support work-life balance to ensure a high-quality client service environment. Join us to make a positive impact on patient safety and global healthcare.
Role Overview:
The Safety Systems Specialist will serve as a key technical expert within the PV Client Success & Safety Systems IT team. This role focuses on the Argus Safety database, database migrations, system configuration, reporting, and validation, ensuring regulatory compliance and optimized safety data management.
Key Responsibilities:
1. Pharmacovigilance Systems Expertise:
Act as a subject matter expert for Argus 8.x Oracle Cloud and associated system integrations (OAS, Axway, Argus Insight).
Lead client data transfers, including imports, exports, and data migrations using strong SQL/PLSQL skills.
Configure and validate pharmacovigilance master tenant enterprise for client enterprise creation.
Lead safety database and associated systems upgrades/patches, including planning, testing, and implementation.
Provide technical support and troubleshooting for internal teams and external clients.
2. Reporting & Analytics:
Develop, validate, and implement standard and custom reports within company reporting tools.
Query databases to support inspections, audits, and regulatory reporting.
Proactively identify opportunities to improve database efficiency and end-user performance.
3. Project Management & Client Support:
Lead client enterprise creation projects from kick-off to delivery, gathering functional and technical requirements.
Manage and escalate system issues with software vendors as required.
Assist in authoring SOPs, work instructions, and forms for pharmacovigilance systems.
Mentor staff and provide training through workshops and one-on-one sessions.
4. Compliance & Quality:
Ensure adherence to global pharmacovigilance regulations, company policies, and system validation standards.
Maintain professional and technical knowledge through continuing education and professional development.
Qualifications & Skills:
Bachelor’s degree in Information Technology or equivalent experience.
7–10 years of experience in pharmacovigilance systems, specifically Argus Safety.
Strong SQL/PLSQL skills and experience in data migrations, reporting, and configuration.
Knowledge of pharmacovigilance processes and ability to translate them into technical solutions.
Experience with system validation, compliance, and global regulatory standards.
Excellent project management, analytical, and problem-solving skills.
Strong communication skills and ability to work effectively within a global team.
Why Join PrimeVigilance:
Work on a wide range of impactful projects in pharmacovigilance.
Recognition for achievements and contributions.
Opportunities for career growth in a growing company with a strong global reputation.
Contribute to patient safety and healthcare improvement globally.
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