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

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).