This position oversees case processing activities, staffing, processes, procedures, and interdepartmental projects involving PV case processing. This position collaborates within CSPV, interdepartmental teams, global teams, and interacts with CROs, vendors, partners, and study teams on all aspects related to case processing. This level oversees the PV role contributing to local and global aggregate reports. This level manages case processing issues, escalating to senior management, as needed. This level participates in hiring, compensation and personnel management decisions.
- Case Processing: Oversees daily case processing staff assignments, activities, and projects. Interacts with vendors, CROs, and partners on a daily and as-needed basis. Escalates issues and develops resource strategy with senior management. Oversees CAPA implementation. Oversees metrics and management of staff administration including work schedules, rewards and discipline. Conducts mid-year and annual performance reviews of direct reports, contributes to compensation and hiring decisions.
- Vendor Case Processing Oversight: Lead for PV CRO/vendor projects and ongoing management oversight. Monitors CRO/vendor reports (daily, weekly, monthly as required by project) to ensure quality completion of deliverables Responds to and manages escalated issues. Identifies and arranges for CRO/vendor training as needed. Works with Strategic Partner Management Lead to manage relationship with CROs and Vendors.
- Case Processing Policies and Procedures: Reviews, approves, and provides input on SOPS, SOIs, process guides, PV Agreements. Participates in inspection preparation activities, internal / external audits and CAPA preparation.
- PV Representative on Study Teams: PV contact for study teams as needed and oversees staff assignments on study teams. May attend multidisciplinary study team meetings and provide management oversight of initiatives and trouble shooting. Participates in Study Start up activities related to case processing as needed. Represents PV for review and comment on interdepartmental and CRO/vendor and partner projects.
- Aggregate Reports: Participates in the preparation of routine and ad hoc Case Processing Compliance and Volume Reports. Oversees PV role in local and global aggregate reports and partner reporting requirements.
- Case Processing Training: Reviews and approves case processing training materials.
- Management Strategy and Goals: Develops PV goals, continued compliance and strategy for process improvement initiatives with senior management and PV management team.
Education and Experience
- Bachelor’s degree in nursing, pharmacy, life sciences, health care or related field;
- Minimum of three (3) years of management experience in PV;
- Minimum of ten (10) years of Drug Safety/Pharmacovigilance experience, including both investigational and marketed products;
- Extensive knowledge of AE and drug coding conventions (MedDRA, WHO-DD).
- Extensive knowledge of FDA regulations, clinical and safety databases,
- Familiarity with Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP)
- Ensures high quality work is completed throughout the function and that internal and external expectations and timelines are met.
- Develops functional strategic plans, provides guidance on priorities within the function and leads implementation.
- Expertly identifies issues independently, thoroughly understands cause of issues, recognizes functional impact, develops and implements solutions.
- Expert scientific knowledge is used to provide leadership and to serve as subject matter expert throughout the function.
- Routinely interfaces, collaborates, and negotiates with project and functional leaders to drive results and resolve complex issues.
- Assists in driving timely management decisions, appropriately shifts functional timelines, resources and priorities to address regional needs.
- Applies clinical trial knowledge to influence strategy and promote efficiency and compliance for assigned projects within the team and externally.