Manager/Senior Manager, Drug Safety & Pharmacovigilance

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?

This role is mainly responsible for participating in the Drug Safety and Pharmacovigilance activities as follows:
1. Operational works on Pharmacovigilance (PV) and Post-Marketing Study (PMS) activities,
2. Training relating to PV and PMS activities,
3. Quality control and assessment on PV and PMS activities,
4. Record management on PV and PMS activities,
5. Vendors/Temporary staff management, and
6. Supporting for communication with regulatory authorities.

• Ensure all regulatory safety documents are processed and submitted according to regulatory requirements and timelines

• Critically draft or review documents produced for regulatory agency safety inquiries in terms of scientific content and alignment with company position, clarity, accuracy, and consistency and facilitate document review by other contributors

• Lead the ongoing review and analysis of product safety data in charge. Implementation and maintenance of safety database and establish the processes of handling case reports with safety database.

• Interface with other Insmed functional groups such as Regulatory Affairs, Clinical Development, Medical Affairs, Quality, business units, as needed

• Lead on-going process enhancement for safety operations such as developing standard procedures and templates

• Manage the courteous and good relationship with PV providers and internal personnel

• Lead the development, production, and maintenance of the appropriate tracking and compliance tools, reports, plans, tasks and activities pertaining to the management of the PV activities

• Collaborate with global safety physicians, and other functional groups in identification, analysis for contributing to development & maintenance of product safety profile

• Support and/or draft regulatory inquiry responses related to PV and safety issues to regulatory agencies, Ethics Committee (EC) and/or Institutional Review Board (IRB), Investigators, and ad hoc inquiries

• Manage planning and conducting PMS activities for Insmed products with local vendors

• Provide input and review to key regulatory or clinical documents (i.e., clinical study reports, investigator brochures, integrated summaries of safety, development safety update report (DSUR), etc.) related to PV

• Lead and participate in internal global PV meetings as well as joint safety meetings with partners if needed

• Collaborate with designated Contract Research Organizations (CROs) and Vendors, as assigned by the PV Head

• Responsible for PV inspection readiness activities and quality in collaboration with Insmed Quality Assurance

• Lead the process for produce local aggregate safety reports, including J-DSUR, to meet regulatory and internal deadlines.

Who You Are:

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

Current Insmed Employees: Please apply via the Jobs Hub in Workday.

Insmed Incorporated is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application   or interview process, please contact us by email at TotalRewards@insmed.com  and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.