Full-Time Safety Systems Specialist

The Safety Database Specialist will work as part of the PV Client Success and Safety Systems IT Team and will be responsible database related activities including data migrations requiring strong SQL developer skills, for providing technical expertise on pharmacovigilance systems, specifically the Argus Safety database, including planning and validation.

The role is critical to pharmacovigilance to support and maintain the overall adverse event reporting system, electronic reporting to health authorities and ensuring compliance to the relevant regulatory requirements, policies and standards.

• Serves as subject matter expert for pharmacovigilance systems (Argus 8.x Oracle Cloud) and associated application integrations (eg OAS, Axway)
• Lead client data transfers (data imports and exports), SQL developer skills required, including prior experience in data migrations.
• Lead development, validation and implementation of standard and custom reports within company reporting tools. Query database to support inspections as required.
• Proactively identifies database requirements to maximize efficiency and quality of end user performance; takes initiative to investigate, develop and implement solutions. Proactively presents solutions to management.
• Manages the configuration/validation of the pharmacovigilance master tenant enterprise used for client enterprise creation.
• Lead project kick-off for client enterprise creation, validation and configuration. Gather functional and technical requirements. Provide configuration solutions to support client case processing and reporting.
• Leads safety database and associated systems upgrades/patches for the IT team, including project planning, testing and implementation.
• Manage and escalate system issues with the pharmacovigilance software vendors as needed.
• Assist with authoring pharmacovigilance system work instructions, standard operating procedures and associated forms.
• Maintains professional and technical knowledge through continuing education, such as workshops, reviewing professional publications, participating in professional organizations
• Accept project assignments as delegated by senior staff, as needed.
• Develops staff knowledge of the safety database through individual mentoring, classroom trainings, user workshops as needed
• Ensure compliance with relevant company policies and procedures.

Requirements:

• Bachelor's degree in Information Technology or related experience
• Demonstrated knowledge and experience with pharmacovigilance systems in a pharmaceutical company, biotech or CRO (on premise or cloud-based solution).
• Demonstrated knowledge and experience supporting Oracle Argus Safety system and application integrations (eg OAS, Argus Insight, Axway)
• Demonstrated understanding of pharmacovigilance processes, ability to translate into technical solutions and implement within the pharmacovigilance system.
• Proficient SQL and/or PS/SQL skills
• System technical subject matter expert for internal and external end users/clients.
• Excellent people and project management skills required.
• Experience with system validation and compliance with global regulations
• Excellent prioritization skills, strong analytical/problem solving skills and ability to multi-task preferred.
• Excellent oral skills, written communication skills and commitment preferred.
• Ability to work within a global Safety Information Systems team

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