PV Operations for Clinical Study Management
• Serve as the PVO Lead for assigned products, representing PV operations in cross-functional clinical team meetings.
• Support SAE reconciliation activities in partnership with Clinical Operations and Data Management.
• Track and manage Reference Safety Information (RSI) updates and ensure timely dissemination across study teams and systems.
• Contribute to the safety content of clinical study documents, including Study Protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), Investigator Brochures (IB)/RSI, and other relevant study documentation.
• Maintain accountability for the data integrity of safety data outputs from the Safety Database for aggregate reports, Health Authority requests, and other safety requirements.
• Manage the drug safety mailbox.
ICSR Management & Case Processing Oversight
• Own end-to-end ICSR management, including in-stream quality review, regulatory submission oversight, and retrospective quality review to ensure timeliness, accuracy, and compliance with global regulations.
• Generate reports and listings/line-listings (LLs) from the Global Safety Database (GSDB) to support SAE reconciliation, Analysis of Similar Events (AOSE), Safety Signal Assessment Reports, and Aggregate Safety Reports (ASRs).
• Monitor case processing metrics and drive resolution of quality or timeliness issues.
Cross-Functional Collaboration
• Partner closely with Clinical Operations, Data Management, Regulatory Affairs, and Medical Safety to ensure alignment on safety data flow, reconciliation, and reporting timelines.
• Act as a key liaison between PV and other functions for assigned products throughout the product lifecycle.
• Provide oversight of outsourced PV activities and vendors, establishing and monitoring key quality and compliance metrics (KPIs/KQIs).
• Ensure vendor performance aligns with contractual, quality, and regulatory expectations; drive corrective actions as needed.
• Support management of PV Agreements/Safety Data Exchange Agreements (SDEAs) with license partners.
Audits, Inspections & Compliance
• Participate in and support internal audits, regulatory inspections, and associated CAPA development and tracking.
• Build and maintain PV infrastructure, systems, and processes to ensure inspection readiness and launch readiness in compliance with global PV regulations and guidelines (e.g., FDA, EMA, ICH).
• Develop and maintain PV operations and compliance related SOPs and work instructions.
Strategic & Departmental Contributions
• Develop short- and long-term goals for the PVO function in alignment with broader departmental and organizational objectives.
• Lead or contribute to PVO-related initiatives, process improvements, and system implementations as assigned.
• Perform other duties as required.