Career Category
Safety
Job Description
The Pharmacovigilance Operations Senior Manager provides strategic leadership and operational oversight of the global safety system and associated data mart to ensure accurate, compliant, and timely safety data analytics and reporting. This role is accountable for driving system performance, data integrity, inspection readiness, and regulatory compliance while advancing adoption of automation, artificial intelligence (AI), and cutting-edge technologies across the pharmacovigilance ecosystem. Operating with a high degree of autonomy, the Senior Manager partners closely with Pharmacovigilance stakeholders to deliver scalable, future-ready solutions that enhance efficiency, insight generation, and regulatory confidence.

Key Responsibilities
Global Safety Systems & Data Governance
- Provide leadership and oversight for changes, enhancements, and configurations of the global safety system and associated data mart.
- Own data integrity, consistency, and reliability standards for safety data used in analytics, regulatory submissions,



and decision-making.
- Oversee system configurations, including reporting rules, product and study setup, and integration points.
- Direct and govern User Acceptance Testing (UAT) activities to ensure validated, inspection-ready system changes.
- Partner with Safety Technology and Managed Services to optimize system performance, support models, and service delivery.

Safety Data Outputs & Regulatory Reporting
- Own the strategy, prioritization and delivery of safety data outputs supporting: Periodic safety reporting (e.g., PADER, PSUR, DSUR), Signal detection and safety surveillance & Regulatory inquiries, audits, and inspections
- Ensure timely, high-quality delivery of automated and scheduled safety reports.
- Establish quality oversight, peer review standards, and continuous improvement for safety data outputs.
- Lead the definition and implementation of reporting solutions, including: User-defined repo

📌 Pharmacovigilance Operations Senior Manager (Hyderabad)
🏢 AMGEN
📍 Hyderabad