Team Lead/ Assistant Manager - Pharmacovigilance Technology

Key Responsibilities

• Implement and manage safety databases and perform data migrations using mapping documents, scripts, and execution activities.
• Configure gateways for data interchange and support IT compliance activities.
• Support technology solution development and deployment, including administration, implementation, validation, upgrades, bug fixes, change requests, and product support.
• Support requirements gathering, development, testing, validation, deployment, operations, and retirement across the product lifecycle.
• Apply pharmacovigilance knowledge to implement, operate, and improve technology solutions.
• Support projects including case processing, literature monitoring, aggregate reporting, medical writing, signal detection and management, medical information, and risk management.
• Own assigned projects and tasks while meeting timelines and quality expectations.
• Manage quality, compliance, and documentation across pharmacovigilance projects.
• Train and mentor personnel and identify training and development needs.
• Represent the department during audits and inspections and support computer system validation activities.

Role Capabilities

• Apply core pharmacovigilance knowledge and experience to technology solution implementation and improvement.
• Coordinate with developers, IT experts, CSV teams, QA teams, and cross-functional client teams.
• Support quality, compliance, documentation, audits, inspections, and applicable regulations and guidelines.
• Provide line management for assigned personnel.

Functional Scope