Pharmacovigilance Operations Senior Manager

Amgen · Hyderabad, India

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Role summary

Amgen seeks a Pharmacovigilance Operations Senior Manager to lead global safety systems, data governance, and regulatory reporting. The role requires strategic oversight of system performance, data integrity, automation initiatives, and inspection readiness across the pharmacovigilance ecosystem.

What they're looking for

Deep expertise in pharmacovigilance safety systems, preferably ArisGlobal LifeSphere
Strong experience with reporting and analytics platforms such as Cognos, Spotfire, or Tableau
Working knowledge of Oracle databases, Oracle Developer, and programming languages like Python or PL/SQL
Strong understanding of global pharmacovigilance regulations and safety reporting requirements
Proven ability to lead complex cross-functional initiatives with minimal oversight
Pharmaceutical industry experience and prior pharmacovigilance systems or regulatory reporting support
Bachelor's degree and 5 years of directly related experience, or equivalent education and experience combination

What you'll be doing

Provide leadership and oversight for global safety system changes, enhancements, and data governance standards
Own strategy and delivery of safety data outputs including periodic safety reporting, signal detection, and regulatory inquiries
Lead study start-up and systems integration activities, including EDC-safety database integrations and UAT execution
Define and drive roadmap for automation, AI, and advanced analytics within pharmacovigilance operations
Maintain inspection readiness and serve as primary representative for health authority inspections and audits

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Date posted16 days ago

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