iVigee, a leading pharmacovigilance services and technology company focused on creating simple, powerful, and elegant drug safety solutions that span the entire drug safety life cycle, is seeking a new team member for the position of Head of Argus Database Systems. The ideal candidate should be based in the Boston Metro area and/or East Coast.
We combine years of experience with the latest… innovative AI technologies to create the ‘instant pharmacovigilance department’, deployable anywhere, on-demand.
Our teams support clients around the world with progressive pharmacovigilance and data management requirements from our strategic bases in Europe and the US.
iVigee: Simple. Powerful. Elegant.
Purpose of the job position
The Head of Database Systems will be responsible for managing and overseeing the safety database systems, ensuring the reliability, scalability, and security of pharmacovigilance data. This includes the configuration, maintenance, and optimization of Argus safety database. The role is critical in supporting regulatory compliance, operational efficiency, and the long-term data strategy of iVigee. The ideal candidate will have strong leadership skills, deep technical expertise, and experience in the pharmaceutical and pharmacovigilance domain.
MAJOR TASKS AND RESPONSIBILITIES:
Leadership & Strategy:
• Lead and manage the database systems team, ensuring alignment with iVigee’s goals and regulatory requirements.
• Develop and implement a long-term strategy for database system scalability, performance, and security.
• Collaborate with IT, pharmacovigilance, and regulatory teams to ensure database solutions meet operational and compliance needs.
Argus Database Management:
• Oversee the configuration, optimization, and maintenance of Argus safety database.
• Ensure data integrity, security, and compliance with global pharmacovigilance regulations (e.g., EMA, FDA).
• Manage system upgrades, patches, and enhancements to ensure optimal performance and uptime.
Compliance & Security:
• Implement and maintain strict data security protocols in accordance with regulatory standards.
• Ensure systems comply with GDPR, FDA, EMA, and other relevant regulations regarding adverse drug reaction reporting.
• Prepare for and support audits and inspections related to database systems.
System Performance & Optimization:
• Monitor database performance and troubleshoot issues as they arise.
• Implement data redundancy, backup, and recovery processes to ensure system availability and data protection.
• Collaborate with IT to integrate the safety database with other company systems (e.g., reporting tools or analytics platforms).
Project Management:
• Lead database-related projects, including new implementations, migrations, validations and integrations.
• Ensure timely delivery of projects, manage budgets, and allocate resources effectively.
• Develop relationships with clients to ensure service satisfaction
SPECIFIC REQUIREMENTS FOR THE POSITION:
Education
• Bachelor’s or Master degree in Computer Science, Life Science, Information Technology, or related field.
• Advanced degrees or certifications in database management or pharmacovigilance systems preferred.
Experience
• 10+ years of experience in database management, including 3+ years in a leadership role.
• Expertise in pharmacovigilance safety databases (preferably Oracle Argus)
• Proven experience managing database systems in a regulated environment, preferably within the pharmaceutical or healthcare industry.
• Experience with the validation of GxP regulated systems specifically, the Oracle Argus.
Skills
• Strong knowledge of Argus safety database architecture, configuration, and optimization.
• Subject matter expertise with the operational use and administration of the Oracle Argus
• Familiarity with regulatory requirements (e.g., GVP, FDA, EMA) and best practices in pharmacovigilance data management.
• Experience with IT security, data integrity, and system auditing processes.
• Leadership and project management skills, with experience leading cross-functional teams.
• Excellent communication skills, with the ability to work with both technical and non-technical stakeholders.
• Strong problem-solving skills and ability to manage complex projects.
• Excellent organizational and multitasking abilities.
• Ability to work under pressure and meet tight deadlines.
• Proactive and innovative mindset with a strong attention to detail.
Language skills
• Strong oral and written English communication skills
Company: iVigee
Location: Anywhere
Salary Range:
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