Senior Patient Safety Vendor Management Manager

Job Description Job Description Key Responsibilities Exercise considerable latitude and apply extensive pharmacovigilance knowledge and technical expertise in determining and implementing strategies consistent with the unit's functional and corporate goals Manage Patient Safety Vendor Management responsibilities and maintain oversight toward Patient Support Programs (PSP), Market Research Programs (MRP), call centers, digital health initiatives/activities, social/digital media monitoring services, and Registries including contract review and negotiation, management of PVA requirements, and supplier relations Oversee safety information reconciliation and QC activities from suppliers and corporate partners to ensure compliance with PVA requirements Support development and maintenance of the Pharmacovigilance System Master File (PSMF) and ensure accuracy and completeness of data collection programs and associated PVAs in the Global Patient Safety PV Oversight System Monitor and manage the Patient Safety Contracts Management mailbox and assign and delegate tasks as appropriate Understand Patient Safety case processing and contracting operations including tools and systems used, exceptions processes, and workflows Collaborate with all units within Patient Safety, other business areas, GBS-BLR and Global Patient Safety to ensure late reports from suppliers and business partners are correctly identified and documented per relevant SOPs and reported to management Perform proper root cause analysis, identification, documentation, correction, corrective and preventive action as appropriate Support internal and external training activities related to contract and vendor management Provide guidance to contract owners and other stakeholders on safety reporting requirements, including PVAsContribute to business continuity and resource planning and ensure adequate coverage for essential tasks at all times Provide strategic input and contribute to process and quality improvement initiatives Guide the successful completion of major programs or initiatives and may function in a project leadership role Participate in onboarding and training of new Patient Safety Vendor Management staff and contingency workers Ensure compliance with all Federal regulations, guidance, and company SOPs regarding safety information reporting from post-marketing sources and clinical trials complaint handling Ensure local/affiliate PVA templates meet both Global and local regulatory requirements Provide audit and inspection readiness and support Develop and maintain company pharmacovigilance SOPsMaintain up to date knowledge of regulations and guidelines issued by FDA and ICHLiaise with suppliers and corporate partners on safety reporting and monitoring issues as appropriate Serve as primary contact, facilitator and communicator of information to other departments concerning contracts, vendors and PVA requirements related matters

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