Position: Safety Systems Specialist
Location: Remote (Employees can work from home)
Employment Type: Full-time
Department: PV Client Success & Safety Systems IT
About PrimeVigilance (Part of Ergomed PLC)
Founded in 2008, PrimeVigilance is a specialized mid-size pharmacovigilance service provider that has achieved consistent global organic growth. With teams across Europe, North America, and Asia, we deliver high-quality services in:
Medical Information
Pharmacovigilance
Regulatory Affairs
Quality Assurance
We provide first-class support to pharmaceutical and biotechnology companies of all sizes, building long-term partnerships and delivering expertise across all therapeutic areas, including medical devices.
At PrimeVigilance, we:
Invest heavily in training and professional development
Promote employee well-being and mental health
Encourage a healthy work-life balance to ensure long-term employee satisfaction and superior client service
Join us and contribute to our mission of making a positive impact on patients’ lives.
Position Overview
As a Safety Systems Specialist, you will join the PV Client Success and Safety Systems IT Team, playing a vital role in supporting and maintaining pharmacovigilance systems (specifically Oracle Argus Safety 8.x Cloud) and ensuring compliance with global regulatory standards.
This role requires a strong background in SQL development, data migration, system validation, and pharmacovigilance process understanding.
Key Responsibilities
System Management & Technical Expertise
Serve as subject matter expert (SME) for pharmacovigilance systems (Argus 8.x Oracle Cloud) and associated integrations (e.g., OAS, Axway).
Lead and support client data transfers, including imports, exports, and data migrations using advanced SQL developer skills.
Develop, validate, and implement standard and custom reports within reporting tools; perform database queries for inspections as required.
Identify and implement system improvements to enhance efficiency and end-user experience.
Manage configuration and validation of the pharmacovigilance master tenant enterprise for client setup and enterprise creation.
Project Leadership & Implementation
Lead client enterprise creation, including project planning, requirements gathering, configuration, and validation.
Drive system upgrades, patches, and testing for the Safety Systems IT team.
Coordinate issue management and escalation with pharmacovigilance software vendors.
Documentation & Compliance
Author and maintain standard operating procedures (SOPs), work instructions, and system documentation.
Ensure compliance with global regulatory requirements, policies, and internal standards.
Participate in system validation activities to maintain compliance and audit readiness.
Training & Mentorship
Conduct user training sessions, workshops, and mentoring programs to strengthen staff knowledge of the safety database.
Provide technical guidance and support to both internal teams and external clients.
Professional Development
Stay current with advancements in pharmacovigilance systems through continuous learning, professional publications, and participation in industry workshops.
Accept and manage project assignments delegated by senior management.
Qualifications
Education & Experience
Bachelor’s degree in Information Technology, Computer Science, or related discipline (or equivalent experience).
Proven experience with pharmacovigilance systems in pharmaceutical, biotech, or CRO environments (on-premise or cloud).
Hands-on experience with Oracle Argus Safety System and integrations such as OAS, Argus Insight, and Axway.
Technical Skills
Strong SQL / PL-SQL programming and data management skills.
Expertise in system validation, system configuration, and data migration.
Strong understanding of pharmacovigilance processes and ability to translate operational needs into technical solutions.
Soft Skills
Excellent project management and communication skills (written and verbal).
Strong analytical, problem-solving, and prioritization abilities.
Ability to multi-task and work effectively in a global, cross-functional team environment.
Why Join PrimeVigilance?
Opportunity to work on a diverse range of global projects and clients.
Recognition and appreciation for your achievements and contributions.
A growing organization offering clear career advancement opportunities.
A reputable company with strong relationships with both clients and employees.
A chance to make a real difference in people’s lives through impactful pharmacovigilance work.
Join Us
If you’re passionate about safety systems, data integrity, and innovation in pharmacovigilance, PrimeVigilance offers the ideal platform to grow and contribute meaningfully.
Be part of our mission to improve patient safety worldwide — apply today!
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