Drug Safety Operations Manager - Pharmacovigilance Job at Talent Groups, Waltham, MA

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  • Talent Groups
  • Waltham, MA

Job Description

Job Description

Overview:

Seeking a Senior Manager, PV Operations to support daily drug safety activities across clinical and post-marketing programs. This role oversees outsourced case processing, ensures compliance with global PV regulations, and supports the team during an upcoming transition to the Argus safety database.

Key Responsibilities:

  • Manage day-to-day PV operations and vendor oversight
  • Review case processing, QC activities, metrics, and CAPAs
  • Lead SAE reconciliation between safety and clinical databases
  • Ensure compliant safety data exchange and adherence to SOPs/regulations
  • Support audits, inspections, and system implementation initiatives

Must Haves:

  • Vendor oversight, reconciliation, retro QC, and Argus database experience
  • Experience supporting/leading database transitions (preferably to Argus)
  • Strong PV operations background within pharma/biotech

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