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Director, GSPV Operations, Process, Quality, and Compliance
3 months ago
Title: Director, GSPV Operations, Process, Quality, and Compliance
Reports to: Vice President, Global Safety and Pharmacovigilance
Location: Remote Position
Position Overview
The Director Global Safety and Pharmacovigilance (GSPV) Operations, Process, Quality and Compliance is responsible for the establishment, maintenance and oversight of appropriate procedures, metrics, and systems to assure compliance to global regulatory requirements for the collection, processing, and reporting of safety information throughout the product life cycle, (pre- through post-marketing). The incumbent serves as a strategic partner in managing GSPV quality and will provide support and collaboration internally and externally to ensure all systems, processes and outcomes comply with applicable global regulations and guidances, and industry and Company standards. This role will be deployed across the key areas of process and performance within the GSPV Operations remit: safety report case management, quality & compliance, safety agreements, and vendor management.
Responsibilities
Develop GSPV strategy and infrastructure for GSPV processes, quality, and compliance; lead departmental process improvement
Develop, implement, maintain, and revise GSPV documents, including but not limited to: GSPV SOPs/WIs, PSMF, SDEA's, other GSPV related documents and policies
Develop and monitor quality control parameters for GSPV processes and assume responsibility for ensuring internal reviews and quality checks are performed and documented
Develop, monitor, and assess compliance metrics to ensure compliance goals are met
Establish and maintain Pharmacovigilance inspection readiness in collaboration with GSPV subject matter experts (SMEs) and Clinical Quality Assurance; function as company's representative during regulatory agency inspections and vendor audits; author responses to audit/inspection findings relevant to functional area
Support strategic direction with cross functional working groups to identify and mitigate GSPV quality and compliance gaps/issues/risks
Function as operational lead for case management, including but not limited to vendor oversight, forecasting, budgeting, compliance, key performance indicators, and training, as applicable
Author and maintain various pharmacovigilance documents, including but not limited to safety management plans, safety data exchange agreements, safety handling plans, or business partner contracts or agreements and memorandum, as applicable.
Oversee and monitor activities of vendors/CROs/business partners to ensure adherence and compliance with applicable study protocols, Safety Management Plans, SOPs and WIs, defined metrics, and contractual agreements
Lead GSPV training curricula development and maintenance in conjunction with Clinical Quality Assurance
Develop, review, maintain, and revise relevant GSPV document templates (e.g., SAE report forms, safety data entry guidelines, DSURs, etc.).
Monitor industry best practices, changes in global safety regulations and guidances and, based on changes, develop and/or modify to departmental plans, policies, and procedures, as needed
Supervise and provide oversight of operations personnel (direct reports, consultants, and vendors) including mentoring, training, and monitoring compliance, as applicable
Other duties as assigned
Requirements
Education and/or Experience:
Masters degree in relevant field (Life sciences), nursing degree or pharmacy degree required; for exceptional candidates, a Bachelor of Science Degree in Life
