Remote Associate Director, Pharmacovigilance Operations

Summary

Join us today as an Associate Director, Pharmacovigilance (PV) Operations to set up and manage the Drug Safety and Pharmacovigilance Group's operational systems and processes. This role includes creating a corporate training program for pharmacovigilance, overseeing safety studies, handling performance metrics, quality control of safety cases, and ensuring SAE and SUSAR reporting meets global compliance standards.

Responsibilities

• Responsible for the day-to-day management and execution of Drug Safety/PV operations
• Responsible for oversight of all aspects of case processing including but not limited to triage, data entry, narrative writing, medical review, follow-up, AOSEs, SUSAR reporting, and query resolution
• Oversee day to day activities related to case processing workflow, safety mailbox, and reconciliation
• Oversee daily interactions with Sponsors, vendors, tracking case progress and adherence to timelines
• Provide technical and case management support to ensure accurate and complete information in the safety database
• Ensure global clinical trial case reporting is efficient and meets safety management plan requirements
• Contribute to aggregate report review and approval
• Develop and maintain pharmacovigilance SOPs and training, and lead quality management and compliance plans
• Track compliance metrics and assist with corrective action plans from audits and inspections
• Prepare and/or review of safety training materials and manage, train and mentor staff, consultants, and/or contractors
• Responsible for coaching and development of direct reports by providing an environment that encourages ongoing personal and professional development
• Assist with the planning, coordination, and management of internal and external safety resources to accomplish assignments to the highest quality standards within the given deadlines
• Participate in regulatory inspections and sponsor/company audits and prepare response to audit findings concerning the Drug Safety department
• Support Precision leadership in strategic planning and other duties as assigned