(Exclusive) Safety Lead at a Global Lifescience Company

About the Role

A leading global life sciences services organization is seeking its first Safety Lead in Japan to establish and lead local pharmacovigilance (PV) operations. This is a high-impact, hands-on role where you will take ownership of building PV infrastructure from the ground up, ensuring full compliance with Japanese GVP regulations while aligning with global safety standards.

You will act as the key safety leader in Japan and a critical bridge to global PV teams. As the organization continues to grow in the region, this role offers strong potential to expand into team leadership and shape the long-term PV strategy locally. Location: Tokyo, Japan Function: Regulatory Affairs, Quality & Pharmacovigilance Reporting to: Regional Head of Patient Safety Requirements Key Responsibilities Establish and maintain local PV and medical device vigilance systems in compliance with Japanese GVP Align local PV processes with global systems and contribute to international safety activities Manage PV documentation (SOPs, training records, etc.)

and ensure audit readiness Deliver and track GVP training for internal and external stakeholders Oversee collection, evaluation, and reporting of adverse drug reactions (ADRs) Ensure timely case processing and submissions to regulatory authorities Act as the main point of contact for safety-related queries and regulatory communication Collaborate with vendors, CROs, and distribution partners Review safety deliverables (ICSRs, CIOMS) and monitor partner performance Support labeling activities, including package insert updates and compliance Work cross-functionally with QA, Regulatory, Clinical, and Commercial teams Serve as the primary PV contact for both local and global stakeholders Key Requirements 5+ years of pharmacovigilance experience in Japan Strong knowledge of GVP, GPSP, ICH, and Japanese regulatory requirements Experience working within global PV frameworks and safety systems Business-level fluency in both Japanese and English Comfortable in a hands-on, autonomous role within a growing organization Preferred Background Experience in PMS, clinical safety, or re-examination activities Exposure to cross-functional areas (QA, manufacturing, supply chain, etc.)

Experience in a global or matrix environment Benefits Opportunity to build PV operations from the ground up in Japan High visibility with regional and global leadership Clear pathway to team leadership and organizational growth Dynamic, international working environment