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Manager/Sr. Manager, Drug Safety & PV

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:

This role is mainly responsible for participating in the Drug Safety and Pharmacovigilance activities including operational works on Pharmacovigilance (PV) and Post-Marketing Study (PMS); training related to PV and PMS activities; quality control and assessment on PV and PMS activities; record management on PV and PMS activities; vendors/temporary staff management, and supporting for communication with regulatory authorities.

What You'll Do:

  • Participate in ICSR case management, as well as the maintenance of safety database and establishment of the processes of handling case reports with safety database, lead the process for local aggregate safety reports including J-DSUR and ensure all regulatory safety documents are processed and submitted according to regulatory requirements and timelines

  • Lead/Participate in ongoing safety data review and analysis for products

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

  • Lead/Contribute to 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

  • Lead/Participate in internal global PV meetings as well as joint safety meetings with partners if needed

  • 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

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

  • Lead/Participate in process for deviations, CAPAs, Effectiveness Check management as assigned

  • Lead/Participate in PV Quality activities such as PV trainings, GVP self-inspection, PV agreement/GVP contract, etc. as assigned

Who You Are:

  • Minimum five (5) years in Drug safety/PV in pharmaceutical industries setting with both investigational and marketed products

  • Working knowledge of relevant FDA, EU, 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 regulations)

  • Knowledge of Drug safety database (Argus) and E2B R3

  • Knowledge of case report management processes including case receipt, case processing, medical review, and regulatory submission

  • Ability to read and collate scientific and medical literature

  • Working knowledge of Medical Dictionary for Regulatory Activities (MedDRA)

  • At least two(2) years of experience with local aggregate safety reporting and J-RMP

  • Bachelor's, Master’s or Doctorate level degree in pharmacy, nursing, or other healthcare-related profession or life sciences required

  • Additional Master’s in Public Health (MPH) or MBA is a plus

Where You’ll Work

This role is based out of our Tokyo office with weekly flexibility to support both your professional and personal needs.

Travel Requirements

This role requires occasional domestic/international travel approximately 10%


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.

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