Senior Specialist or Manager, Pharmacovigilance, Oncology

Job description

Purpose: This position is accountable for executing the day-to-day operations and compliance activities by leading a team of PV operations to maintain high-functioning PV systems across assigned region remit. Reports directly to Japan PV Operational Lead. Responsibilities: Metrics and Oversight of the Pharmacovigilance System - Supports the provision of metrics that will ensure oversight of all aspects of the performance and functioning of the PV system in compliance with local regulations and internal company timelines/standards. - ICSR Management - Records, processes, and conducts follow up and translates adverse events and other safety information from spontaneous and solicited sources. - Performs ICSR expedited reporting according to the local requirements. - Ensures local-language medical or scientific literature review. - Implements an appropriate local quality control (QC) procedure to ensure quality of information entered and report decisions. - Completes AE reconciliation and ensures AE identification effectiveness sampling consistent with global procedures. Periodic Safety Reporting - • Partner with Safety Science and any other relevant functions, leads the preparation of periodic - safety reports of assigned TA' products (J-DSUR, J-PSUR, Non-Serious Unexpected ADR Periodic - Safety Report and Re-examination dossier). - • Ensures submission of periodic safety reports and ensures documentation of evidence. Audits and Inspections - Actively assists in managing internal PV audits, audits of affiliate service providers/third parties and Regulatory Authority PV Inspections. Partnership with business partner with possibility for identification and/or handling of safety information - Ensuring all PV requirements are in place for activities where there is a reasonable possibility for the identification and/or handling of safety information in accordance with AbbVie procedures and local requirements. Risk Management (if applicable) - Collaboration with Safety Science is essential for the following tasks. Do refer to the DOP and JPN GL 04, which are defined separately, for more details. - Develops a deep knowledge of the Risk Management Plans (RMPs) to obtain information on the risk/benefit profile of products, for implementation of EPPV locally. - Liaises with affiliate safety science and where applicable, during development or revision of the COUNTRY RMP (if applicable) Safety Monitoring - For EPPV, understands and monitors incoming local safety data and communicate changes or potential concerns to the affiliate safety science, for evaluation. Launch Readiness - Collaborate with Safety Science and along with Safety Control Manager to ensure the successful launch of new drugs/additional indications in Japan by executing a solid local strategy to ensure local regulatory compliance. Affiliate Review Process for research - Review the assigned TA and products Reg-PMOS protocols from a safety perspective. Qualifications: • A minimum of 2 years’ experience required within the pharmacovigilance or a related field. • Effective communicator and able to work effectively in teams and a cross functional environment. • Strong commitment to compliance with relevant rules and procedures. • Effective planning and organizational skills, and the ability to complete activities with high quality. アッヴィは、機会均等を重視する雇用主であり、誠実な企業活動、革新の推進、人々の生活への貢献、そして地域社会への貢献に努めています。雇用機会均等に向けて、障がいを持つ方々も積極的に支援しています。 About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.