Working with the Head of DSPV-Japan, this role is responsible for ensuring optimal patient safety as first priority by developing a state-of-the-art safety strategy, driving medical safety processes and capabilities and having accountability for safety compliance in Japan.What You'll DoDevelop and maintain a local safety assurance system to support safe use of commercial productConduct or supervision of safety assurance activities, including but not limited to, collection of drug safety reports, examination of safety information received, timely reporting to competent authorities and planning, reporting and implementation of safety assurance measuresConduct self-inspection and support internal process audits and external vendor audits as necessaryContribution to and control of documents related to safety management activities, including, but not limited to, the J-RMP and the J-PSURDevelopment of local SOPs related to safety assurance activities, review or approval of functional area procedures as needed and implementation of associated training requirementsProviding Head of DSPV-Japan with information on changes in the local GVP regulations Communication with necessary parties in the case of communication from the local competent authorities regarding safety matters for the productReporting of any product safety related issues to Head of DSPV-Japan, and the General Marketing Compliance Officer in JapanPlay a key role in cross-functional project for investigational product from development phase including J-NDA through launch, collaborating with colleagues from other functions, e.g. Clinical Development, Medical Affairs, Regulatory Affairs, Medical Information, and QA, as well as externally with expert panels and other scientific contactsEnhance scientific and clinical experience of staff through continuous training and coaching. Participates in building the talent pipeline for key roles in Medical Safety. Responsible for attracting, retaining and developing talent within the PV organization.Collaborate with/support medical safety for medical review and safety assessment activities, including, but not limited to, compiling analysis of similar events (AOSE), individual case comments, RMP analyses, and ad-hoc safety analyses as required by health authorities or corporate policy, and ensure that medical safety signals from aggregate data are identified promptly and communicated/escalated within the PV organization and other functions appropriatelyLead enhancement/improvement of operational process to optimize the efficiency in the organization as necessaryWho You AreBachelor’s degree ter’s degree is preferrableMust have excellent communication and presentation skills (verbal and written / Japanese and English) with the ability to effectively present ideas and influence others that achieve desired resultsMinimum eight (8) years in Drug safety/Pharmacovigilance in pharmaceutical industries setting with both investigational and marketed products. Working knowledge of relevant PMDA, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments (including ICH/CIOMS, Clinical development methodology and knowledge of Clinical Trial guidelines (GCP) and regulation)Knowledge of Individual Case Safety Reports (ICSR) management processes including case receipt, case processing, medical review, and regulatory submissionAt least two (2) years of experience with, aggregate safety reporting, safety surveillance, signal management and/or Risk managementActive participation ulatory inspectionsPeople management and resource/budget planning experiencePreferrable experience of: Minimum two (2) years as a safety officer; Knowledge of pharmacoepidemiology; Ability to review and/or prepare scientific or regulatory documents, from large volumes of scientific information; Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/ submissions involving safety information; Experience in presenting clinical or safety data to major health authorities; Experience with setting up and leading an Early Post-marketing Vigilance Study; Working knowledge of industry standard pharmacovigilance databases (preferably Argus) and MedDRA; Device experience; Project management experienceSkills & Capabilities: Ability to lead others without authority to move internal and external teams towards achieving goals that support Insmed’s key strategic objectives; Demonstrated experience improving, developing and implementing new processes; Flexible, diplomatic and able to effectively deal with ambiguity; Works effectively across functions as a team player; Successful experience in a fast-paced entrepreneurial environment; Highly organized with strong attention to detail, clarity, accuracy, and conciseness; An uncompromising ethical standard and level of conduct are essentialWhere You' ll WorkThe Company’s Head Offi ce in Tokyo - You may work from home according to the guidelines set forth by the CompanyTravel RequirementsThis role requires occasional domestic/international travel (approximately 20%)Life at Insmedインスメッド日本オフィスは、国会議事堂を望む東京の中心部、溜池山王駅直結の好立地に位置しています。最新のワークスタイルに対応したフリーアドレス制を導入し、開放的で柔軟な働き方を実現しています。カフェエリアでは部門を超えた自由なコミュニケーションやコラボレーションを促進する空間を創り出しています。日本法人の拠点として、患者さんにより良い医療をお届けするため、社員一同が一丸となって日々邁進しています。社員一人一人の充実した働き方を実現するためのサポート：ワークライフバランスの実現フレキシブルな勤務時間や充実した休暇制度魅力的な報酬制度退職金制度、株式報酬制度、従業員持株制度（ESPP）への参加機会キャリア開発支援社内研修、外部研修プログラムの活用、LinkedIn Learning、業務に特化した専門研修先進的な学習支援AI搭載の学習ツール、社内リソースへのアクセスを支援するデジタルアシスタントグローバルの表彰制度や従業員リソースグループ活動ハイブリッドワーク環境の整備場所や時差を超えたシームレスな協働を実現する最新テクノロジー、充実したIT支援体制
9 days ago