PMS戦略企画担当者/ スタッフorノンラインマネージャー/医薬開発本部ペイシェントセイフティー&ファーマコビジランス部PMS戦略企画グループ

3週間前

Shinagawa-ku, Tokyo Boehringer Ingelheim

Job Title
Manager, PMS Strategy Planning Group, Patient Safety & Pharmacovigilance

Reporting Line
Head, PMS Strategy Planning Group, Patient Safety & Pharmacovigilance

Location
Japan

Legal Entity
Human Pharma BU_NBI (Nippon Boehringer Ingelheim Co., Ltd.)

Functional Area
Medicine

Basic Purpose of the Job

  • Lead and manage GPSP activities such as PMS planning, vendor management, re-examination, and process standardization according to BI internal procedures and local regulations
  • Plan post-marketing surveillance studies as additional PV plans based on safety specifications in compliance with GVP and GPSP regulations; support PMS execution in collaboration with PMS execution group
  • Monitor key trends related to customers, competitors, and regulatory requirements for PMS in Japan and globally from short- and mid-/long-term perspectives

Key Responsibilities

  • Plan PMS in compliance with GPSP regulations and prepare re-examination dossiers and required materials under the drug re-examination system
  • Lead/manage preparation for re-examination dossiers and inspection readiness
  • Ensure preparation of local periodic safety reports and coordinate review cycles with global product responsible persons at GPV
  • Contribute to establishing local inspection readiness, participate in PV audits and PV/GPSP inspections, and support CAPA processes
  • Contribute to strategy development and implementation to ensure compliance and close medical safety gaps for patients
  • Lead process improvements for efficiency, transparency, compliance, and insightfulness through cross-functional collaboration and data utilization
  • Empower individuals and foster a proactive, leadership-oriented culture
  • Plan and execute PMS strategy aligned with domestic and global academic trends and clinical needs; collaborate with MA and Marketing teams for RWE usage
  • Co-lead strategic design of PMS databases and analyses with Epidemiology team; ensure insights from PMS activities are collected, analyzed, and shared internally
  • Support positive customer experience by engaging with relevant functions and improving CE KPIs

Regulatory & Organizational Requirements

  • Comply with government regulations and company SOPs relevant to QMS, GPSP, and GVP
  • Act ethically at all times

Job Complexity
Requires extensive regulatory, scientific, epidemiological, and medical knowledge, considering cross-functional needs.

Interfaces
Global Patient Safety & Pharmacovigilance, CO&D Japan, Primary Care Medicine, Specialty Care Medicine, LRA, QM, Primary Care BU, Specialty Care BU.

Job Expertise

  • 5+ years' experience in pharmacovigilance and PMS
  • Experience leading projects or taskforces in industry associations (preferred)

Education
Bachelor's Degree (minimum).

Required Capabilities
Knowledge & Experience

  • Strong knowledge of local GPSP/GVP regulations and local/international NIS studies
  • PMS administrative tasks and project management experience
  • Industry activity experience (e.g., working groups across companies) preferred
  • Excellent English (TOEIC >700)

Skills & Competencies

  • Proactive and assertive attitude for team building and networking
  • Problem-solving and analytical skills on industry trends
  • Conceptual and strategic thinking
  • Project management and decision-making skills
  • English CEFR level: B1

Career Path Note (Optional for Candidate Communication)
This role follows an
Individual Contributor track
with opportunities to progress to Senior IC or transition to People Manager based on performance and organizational needs (typically within 1–2 years).

Our Company

Why Boehringer Ingelheim?
With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-