【企業の特徴】
外資系バイオ医薬品企業
<ポジションサマリー>
- 安全管理活動全体を統括し、医薬品の安全性確保、規制順守、リスク管理を推進する役割
- 安全性情報収集・評価、規制当局対応、RMP関連文書管理、治験から市販後までの安全性戦略づくり、部門横断プロジェクト参画、チーム育成など幅広い責任を担う
【仕事内容】
■About the Role
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 Do
- Develop and maintain a local safety assurance system to support safe use of commercial product
- Conduct 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 measures
- Conduct self-inspection and support internal process audits and external vendor audits as necessary
- Contribution to and control of documents related to safety management activities, including, but not limited to, the J-RMP and the J-PSUR
- Development of local SOPs related to safety assurance activities, review or approval of functional area procedures as needed and implementation of associated training requirements
- Providing 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 product
- Reporting of any product safety related issues to Head of DSPV-Japan, and the General Marketing Compliance Officer in Japan
- Play 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 contacts
- Enhance 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 appropriately
- Lead enhancement/improvement of operational process to optimize the efficiency in the organization as necessary
■Travel
- Travel up to 20% (domestic and international), some of which will be overnight in nature
【応募資格】
■Essential
- Fluent in written and verbal English and Japanese
- Bachelor's degree in health care or life science is required, Master's degree is preferrable
- Minimum 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 submission
- At least two (2) years of experience with, aggregate safety reporting, safety surveillance, signal management and/or Risk management
- Active participation in internal audits, regulatory inspections
- People management and resource/budget planning experience
■Preferrable
- 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 experience
【給与】
万円 (スキル・経験により決定)
【Job Reference ID】:
JO
【英語力】:
Fluent
【日本語力】:
Fluent – Native level (Equivalent to JLPT N1)
【待遇・福利厚生】:
リモートワーク制度(ハイブリッド勤務) フリーアドレス制 退職金制度、株式報酬制度、従業員持株制度(ESPP) 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 ほか
【休日休暇】:
完全週休二日制(土曜、日曜、祝日)、年末年始休暇、年次有給休暇
*【選考プロセス】*
:
書類選考、面接数回を予定
雇用形態 :
正社員
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