Full Time

Pharmacovigilance Operations Senior Manager

Amgen
Hyderabad, Telangana
Salary Negotiable
Posted 30/12/2025

About the Role

Key Responsibilities

  • Lead and govern global PV safety systems, data marts, UAT and system validation

  • Ensure data integrity, compliance, inspection readiness and regulatory reporting (PSUR, DSUR, PADER)

  • Oversee EDC–Safety DB integrations and reporting solutions (QBE, dashboards)

  • Drive automation, AI adoption and PV process innovation

  • Develop SOPs, training programs and mentor teams

  • Support audits, inspections and QPPV-delegated activities


Required Skills & Experience

  • Strong experience with Argus / ArisGlobal LifeSphere

  • Knowledge of global PV regulations, SDLC and system validation

  • Reporting tools: Cognos, Spotfire, Tableau; Oracle DB, PL/SQL, Python preferred

  • Pharma / Health Authority experience mandatory


Education

  • Doctorate OR Master’s + 3 yrs OR Bachelor’s + 5 yrs OR Associate’s + 10 yrs OR High School + 12 yrs relevant experience


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