崗位要求： 1. 優(yōu)先1年以上日語(yǔ)PV經(jīng)驗(yàn)人選 2. 日語(yǔ)N2及以上，英語(yǔ)可讀寫 Key Responsibilities: · Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. · To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming - Adverse Events (AE)/endpoint information · Perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs) which includes review of AE coding, past medical history, concomitant medications, expectedness/listedness, causality assessment and other medical information and ensure completeness and accuracy of data according to applicable regulations and guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines and communicate with the team leads for any correction required in the case and maintain appropriate documentation for all communications. · Determining initial/update status of incoming events · Database entry · Ensure to meet quality, productivity, and delivery standards per project requirements. · Ensure compliance to all project related processes and activities. · Maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects · Provide and impart technical and process information to Safety Management and members of operational team on project specific issues. · Liaise with different functional team members, e.g. project management, clinical, data management, healthcare professionals, e.g. investigators, medical monitors, site coordinators and designees to address project related issues. · Liaise with client in relation to details on day-to-day case processing activities. · To mentor new teams members, if assigned by the Manager. · Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes. · Perform other duties as assigned. Key Requirements: ? Bachelor’s Degree in Pharmacy, Nursing or equivalent Scientific or healthcare discipline or allied life sciences ? Experience in Pharmacovigilance in Pharma industry will be an advantage. ? Good knowledge of medical terminology. ? Working knowledge of applicable Safety Databases and any other internal/Client applications. ? Knowledge of applicable global, regional, local clinical research regulatory requirements. ? Excellent attention to detail and accuracy, maintain high quality standards. ? Good working knowledge of Microsoft Office and web-based applications. ? Strong organizational skills and time management skills. ? Strong verbal/written communication skills. Fluent in English, Mandarin, Cantonese and Malay is preferred. ? Self-motivated and flexible. ? Ability to follow instructions/guidelines, utilize initiative and work independently. ? Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands. ? Ability to be flexible and receptive to changing process demands. ? Flexibility to operate in shifts and holiday coverage