Overview
Hybrid
Depends on Experience
Contract - W2
Skills
Auditing
Database
Management
Marketing
Microsoft Exchange
Pharmaceutics
Quality Control
Regulatory Compliance
System Implementation
Job Details
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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