China PV Lead

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About the role

Oversight of the Pharmacovigilance System • Ensures that PV processes, procedures and systems are in place to comply with AbbVie Global PV procedures and with local and/or regional PV regulations. • Maintains oversight of the performance of all activities that fulfil local and applicable regional PV regulations, including those performed by PSEQ the Regional PV Teams and/or outsourced partners, in collaboration with Regional PV Leaders who oversee day-to-day operational PV activities. • (National QPPV / back-up National QPPV only) Maintains oversight of AbbVie’s PV System Master File (PSMF) with the authority to ensure that the information contained is an accurate and up-to-date reflection of the PV system. Quality Management System • Partners with PSEQ the Regional PV Teams to: • Ensure Affiliate PV System procedure(s) aligns with corporate PV procedures and complies with local and regional PV regulations. • Manage any non-conformity and/or planned departures from corporate and/or local PV procedures according to the global issue and exception management process and ensure any corrective/preventive actions are completed according to the schedule. • Maintain oversight of the PV training plan and ensure training compliance of local PV personnel and other affiliate personnel with corporate and local PV training requirements. • Oversee training compliance of partner company staff according to local contract requirements. Adverse Event & Periodic Safety Reporting • Maintains oversight of the PV system and ensures that processes, procedures and systems are in place for intake, processing, conducting follow up, translation and reconciliation of adverse events and other safety information reportable to PPS GPS from spontaneous and solicited sources as well as from clinical studies. • Partners with the Regional PV Teams in  PSEQ   GPS to ensure reporting of both clinical and post-marketing Individual Case Safety Reports (ICSRs) and Periodic and Aggregate Reports to the Regulatory Agencies, Ethics Committees and Investigators, in compliance with corporate PV procedures and with local and regional PV regulations as required. Audits and Inspections • Serves as the Affiliate Lead and point of contact for affiliate PV audits and Regulatory Authority PV inspections, demonstrating understanding of the overall AbbVie PV system and how Global PV processes and PSEQ the GPS Regional PV Teams are set-up and structured, supporting the fulfilment of local legal requirements. • Collaborates with the GPS PSEQ Regional PV Teams in to manage managing audits of processes executed by the Regional PV Teams and as well as audits of affiliate service providers and third parties. • Supports PSEQ Collaborates with GPS Regional PV Teams in the development of CAPA in response to observations and the tracks ing actions to completion in a timely manner. Partnership with business partner with possibility for identi fi cation and/or handling of safety information • Acts as key safety advisor for affiliate cross-functional partners on safety topics  to  address business needs and ensure   ensuring that business partnerships involving activities where there is a reasonable possibility for the identification and/or handling of safety information are assessed for the generation of safety information and the applicable PV requirements, and that applicable PV and safety data exchange agreements are implemented. • Partners with PSEQ the GPS Regional PV Teams to ensure that: • All sources of adverse events and other safety information are identified at the local level and mechanisms are in place for collection and collation of all data by PSEQ GPS. • Content of local Safety Data Exchange Agreements (SDEAs) and other PV agreements conforms to AbbVie procedu

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