Key Facts

Remote From:

Full time

Japanese, English

Hard Skills

Pharmacovigilance Cross-Functional Collaboration Regulatory Compliance Aggregation Analysis Signal Handling Risk Management Risk Analysis Safety Management Systems Postmarketing Surveillance Cross-Functional Collaboration +1 more

Other Skills

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People Management
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Communication
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Leadership
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Teamwork

Roles & Responsibilities

Advanced life sciences degree (e.g., MD, PharmD, PhD, MS) or equivalent healthcare qualification
8-12+ years of PV/drug safety experience with substantial Japan GVP/GPSP execution; prior leadership of affiliate PV operations
Prior experience as a Safety Management Officer（安全管理責任者） in a Japanese organization (GVP GPSP)
Fluency in Japanese (native or business-level) and strong English communication skills, with demonstrated authority interaction experience (e.g., PMDA inspections, safety responses, labeling negotiations)

Requirements:

Oversee the full drug safety system and monitor risks and benefits of all products in Japan
Act as the main contact with regulators and ensure compliance with local rules under GPSP/GVP
Lead and manage PV safety systems and processes in collaboration with global and local teams; supervise 5-6 direct reports
Ensure robust PV deliverables including PMDA submission standards, RMP, signal management, aggregate reporting, and PMS under GPSP

Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC)

Human Resources, Staffing & Recruiting

About Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC)

➡️ HERE IS WHAT WE DO We specialize in searching for and recruiting top talent in the Pharmaceutical and Medical Device Industry in Japan (JPAC) and Asia (APAC) via our Japan and Singapore offices. ➡️ HOW DO WE GET THINGS DONE With nearly two decades of recruitment experience in the Pharmaceutical Industry in Japan and Asia, we have the client-relationship expertise, knowledge, persistence, dedication, and diligence to ensure even the most challenging recruitment searches are successful. ➡️ FOR HIRING MANAGERS Through our extensive contacts with the best, brightest, and most well-prepared candidates in the market, combined with the ability to fully understand our clients' needs, we can quickly provide the perfect solution to your requirements. ➡️ FOR JOB SEEKERS We take the time to listen, understand and present opportunities to you when you are ready. ➡️ WHERE HAVE YOU SEEN US Since 2006, Philip has been writing a monthly column for Pharma Japan. He has also been published in Life Science Leader, The Fordyce Letter and Biosimilar Development. ➡️ WHAT OTHERS SAY "Philip has exceptional knowledge of the Japanese Pharmaceutical Industry. Philip is also dedicated to advancing global business leaders’ knowledge and applied skills through his insightful articles. I have found the articles beneficial in both the business environment and as excellent discussion topics as part of the International Management course I teach at the University of Texas. I highly recommend Philip to support a company's efforts to advance their firm with a "Global Mindset" staff and practices". Scott Manning, Lecturer at San Diego State University and former Country Manager of Alcon Japan "Philip is extremely knowledgeable of the Japanese Pharma Industry and his articles are always very intriguing. He is certainly a person that can identify talent and professionals that could grow and add value to the hiring company" Masaki Nakanishi, Director of Business Development at AnGes, Inc.

Company type: TPE

Industry: Human Resources, Staffing & Recruiting

Founded: 2018

Company size: 11 - 50

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Job description

Role: Head of Pharmacovigilance (PV)
Team: Managing 5–6 direct reports
Workstyle: Remote flexibility with a competitive package

The key requirements for this job are:

1. Prior experience as a Safety Management Officer（安全管理責任者） in a Japanese organization (GVP & GPSP)

2. Strong English communication skills for interactions with global teams

The Head of PV in Japan is responsible for the full drug safety system and monitoring risks and benefits of all products.

They act as the main contact with regulators, ensure all local rules are followed, and work closely with global and local teams to manage safety systems and processes.

Requirements

Advanced life sciences degree (e.g., MD, PharmD, PhD, MS) or equivalent healthcare qualification.
8–12+ years of PV/drug safety experience with substantial Japan GVP/GPSP execution; prior leadership of affiliate PV operations.
Demonstrated authority interaction experience (e.g., PMDA inspections, safety responses, labeling negotiations).
Strong knowledge of PMDA submission standards, RMP, signal management, aggregate reporting, and PMS under GPSP.
Fluency in Japanese (native or business‑level) and strong English communication skills.