Director, Drug Safety & Pharmacovigilance - Japan

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? 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 Who You Are: Bachelor’s degree in health care or life science is required, Master’s degree is preferrable Fluent in written and verbal English Experience & Knowledge Essential: 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, cas ... (truncated, view full listing at source)