Position: Senior Director, Pharmacovigilance Operations Job # 2086
Location: Central NJ
Compensation: Based Upon Experience
This position oversees case processing activities, staffing, processes, and interdepartmental projects involving PV case processing. This position collaborates within CSPV, global teams, DSI sites and interdepartmental teams and interacts with CROs, vendors, and partners. This level oversees the PV role in local and global aggregate reports. This level manages escalated issues and handles case processing process and procedure issues, escalating to senior management, as needed; and participates in hiring, compensation and personnel management decisions.
This position leads teams responsible for:
Clinical Study Startup
Data Management and Safety Systems
Quality, Compliance, and Training
Case Processing: Oversees and manages case processing workload and resources. Reviews metrics to ensure appropriate resource management. Escalates issues and develops resource strategy with senior management as indicated. Maintains and optimizes a high quality, accurate, and timely AE/SAE case processing and evaluation process.
Management Strategy and Goals: Develops PV goals, continued compliance and strategy for process improvement initiatives with senior management and PV management team.
Case Processing Policies and Procedures: Drafts/revises SOPs, SOIs, and process guides, approves CSPV documents, and participates in inspection preparation activities.
Vendor Case Management: Responds to and manages escalated issues. Lead for PV CRO/vendor projects. Works with Strategic Partner Management Lead to manage relationship with CROs and Vendors.
Case Processing Training: Reviews and approves case processing training materials.
PV Representative on Study Teams: Represents PV for review and comment on interdepartmental and CRO/vendor and partner projects.
Aggregate Reports: Participates in the preparation of quarterly Case Processing Compliance and Volume Report. Oversees PV role in local and global aggregate reports and partner reporting requirements.
Education and Experience
Bachelor’s degree in nursing, pharmacy, life sciences, health care or related field;
Minimum of six (6) years of management experience in PV;
Minimum of twelve (12) 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)
PharmD, RN, or Master’s degree in life sciences preferred
Creates a culture of compliance for the function: works cross-functionally to identify risks and trends for the function.
Owns functional strategic plans, defines and manages priorities within the function and drives implementation.
Identifies issues independently, thoroughly understands cause of issues, recognizes functional and global impact, and oversees implementation of solutions.
Uses advanced scientific knowledge to influence PV processes and provides cross-functional leadership.
Interfaces, collaborates and negotiates with internal and external stakeholders to ensure successful results and resolution to complex issues.
Drives timely management decisions, appropriately shifts functional timelines, resources and priorities to address regional priorities.
Applies clinical trial knowledge to promote efficiency and compliance for assigned projects within the function with both internal and external stakeholders.
Ability to develop cooperative working relationships with staff from different cultural and medical backgrounds.
Comprehensive knowledge of ICH principles of SAE/AE reporting along with proficient understanding of local and global regulatory roles and regulations.
Diversified knowledge of in-depth safety policies and procedures in the major countries