Pharmacovigilance Operations Senior Manager Job at Amgen in Hyderabad, Telangana | Jobslly

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

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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

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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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