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Job Details
The Senior Specialist, Pharmacovigilance System serves as the strategic and operational bridge between the Pharmacovigilance (PV) business/operations teams and the technical organization. This individual acts as the system champion, business representative, and end-to-end accountability owner for one or more pharmacovigilance platforms and integrated solutions — ensuring these systems meet regulatory, operational, and quality standards throughout their lifecycle.
This is a highly cross-functional role that requires a unique blend of deep PV domain expertise, systems thinking, stakeholder management, and a forward-looking understanding of emerging technologies including AI.
This person ensures those technical workstreams are effectively directed and aligned to business needs.
Key Responsibilities
System Ownership and Governance
• Serve as the accountable business system owner for PV-related platforms, including safety databases, signal management tools, medical information systems, literature monitoring solutions, and reporting platforms
• Own and maintain the system roadmap, prioritizing enhancements, upgrades, and recent feature rollouts in alignment with business strategy and regulatory requirements
• Lead and manage system lifecycle activities — from business requirements definition, UAT, deployment, through to retirement — ensuring timely and quality delivery of all system milestones
• Maintain and govern all business-owned system documentation, including Business Requirements Documents (BRDs), functional specifications, SOPs, user guides, and validation plans (in close collabor
📌 Senior Specialist, Pharmacovigilance System Noida
🏢 Cencora
📍 Noida