Manager Pvg

Company Name: PPD Development, L.P.

Position Title: Manager PVG

Location: 929 North Front Street, Wilmington, NC 28401

Summary of Duties: Coordinate contracted safety responsibilities for one or more programs, including staffing, training, and procedural compliance. Safety responsibilities include set-up and maintenance of processes such as development and maintenance of the Safety Management Plan, Data Entry Guidelines and other process documents that govern project activities related to receipt, data entry, medical review and safety reporting of ICSRs. Write/update and maintain process documents such as data entry guidelines, safety management plans, case processing timeline documents, and project contact lists which represent various departments internally and externally. Manage the safety team on respective programs. Management of the safety team includes providing direction, training and oversight to ensure compliance with regulatory and contractual timelines as well as adherence to quality standards. Monitor team’s metrics and quality. Ensure team meets the quality expectations per company SOPs and achieves the expected metrics to deliver the project(s) on budget. Act as an escalation point for the internal and external safety project team in resolving issues. Work with senior management and develop consistent internal processes and ensures compliance with established processes. Proactively liaise with the Project Manager (as appropriate) and clients, and ensure optimal performance and utilization of the safety project team. Lead initiatives related to changes in the SAE query process to enhance efficiency. Collaborate with key stakeholders including client and internal project management, data management, clinical and external PV leadership. Responsible for financial management of the safety activities on respective programs. Manage multiple aspects of projects, both local and globally, such as contractual, procedural, and regulatory requirements. Maintain good communications with other functional groups concerning program and company issues. Collaborate with other employees in problem solving and systems improvement. Review regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures, and proposals. Maintain a basic medical understanding of applicable therapeutic area and disease states. May participate in on-call duties for specific projects and ensure 24-hr coverage for intake of cases from investigative sites. Provide plans and accurate forecasts for all projects. Serve as a resource to other departmental managers and lead departmental initiatives. Lead client meetings and prepare minutes/action items related to project updates, issues and solutions for resolution of any issues. Prepare and present proposals. Manage staff of experienced professionals, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Monitor the case processing workflow to ensure contractual and regulatory due dates are met on a daily basis. Be responsible for the workflow and assist team with various activities during times of high volume, compressed timelines, or limitations on staff availability. Approve courses of action on salary administration, hiring, corrective action, and terminations. Review and approve time records, expense reports, requests for leave, and overtime. Duties may be performed remotely.

Qualifications: Bachelor’s degree in Pharmaceutical Science, Medicine, Chemistry, Public Health, Biology, or related field and five (5) years of experience as a Safety Specialist, Operations Coordinator, Research Assistant, Medical Officer, or related role, OR Master’s degree in Pharmaceutical Science, Medicine, Chemistry, Public Health, Biology, or related field, and three (3) years of experience as a Safety Specialist, Operations Coordinator, Research Assistant, Medical Officer, or related role. Must have three (3) years of experience with: Global regulatory requirements and understanding the importance of and compliance with procedural documents; Relevant therapeutic areas as required for processing AEs; Pathophysiology and the disease process; Project management; and Safety databases and Microsoft Office products.

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