Pharmacovigilance Operations Senior Manager
About the Role
Key Responsibilities
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Lead and govern global PV safety systems, data marts, UAT and system validation
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Ensure data integrity, compliance, inspection readiness and regulatory reporting (PSUR, DSUR, PADER)
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Oversee EDC–Safety DB integrations and reporting solutions (QBE, dashboards)
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Drive automation, AI adoption and PV process innovation
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Develop SOPs, training programs and mentor teams
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Support audits, inspections and QPPV-delegated activities
Required Skills & Experience
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Strong experience with Argus / ArisGlobal LifeSphere
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Knowledge of global PV regulations, SDLC and system validation
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Reporting tools: Cognos, Spotfire, Tableau; Oracle DB, PL/SQL, Python preferred
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Pharma / Health Authority experience mandatory
Education
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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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