Risk Management Officer, Japan Pharmacovigilance Team (SVJPE) - Remote

Overview

Santen is a pharmaceutical company with a 130-year history specializing in ophthalmic medicine. As a global company originating from Japan, it has a presence in over 60 countries, providing various innovative treatments and digital solutions for eye health, addressing social issues related to vision worldwide.

The Japan Pharmacovigilance Team is a cross-regional safety monitoring department that strategically monitors the safety of Santen products and clinical trial products deployed globally.

Under a people-centric mindset, you will lead proactive information dissemination to deliver safety and trust to healthcare professionals and patients by utilizing the rich safety and efficacy data held by our department, going beyond regulatory compliance.

In Short

• Responsible for the collection, analysis, and dissemination of safety information for pharmaceuticals and medical devices post-marketing.
• Execute signal management based on accumulated safety information and plan risk management activities.
• Develop and analyze post-marketing survey (PMS) plans and create summary reports.
• Prepare documents such as RMP, periodic safety reports, and ICH-PBRER based on requests from overseas safety vigilance departments.
• Coordinate the issuance of information materials and publications in collaboration with KOLs.
• Maintain and operate the risk management system in response to changes in external/internal environments.
• Evaluate individual cases and report to regulatory authorities.
• Maintain and operate compliance systems in line with changes in regulatory requirements across countries.

Requirements

• 3+ years of experience in either A) Safety department (including risk management) at a pharmaceutical manufacturer, B) Post-marketing survey department (PMS) at a pharmaceutical manufacturer, or C) Research and development department at a pharmaceutical manufacturer.
• Business-level proficiency in Japanese.
• Business-level proficiency in English.

Benefits

• Opportunity to build a career at Santen.
• Flexible working styles and an inclusive workplace environment.
• Engagement in global projects and collaboration with diverse teams.
• Contribution to innovative treatments and understanding for patients.