Patient Safety Associate, Patient Safety & Risk Management
📍 Tokyo | 🏠 Hybrid | 🕒 Full-Time
Deliver Excellence in Pharmacovigilance
Join Our Patient Safety Team as a Patient Safety Associate and assist in the day-to-day delivery of pharmacovigilance and safety related projects, including processing safety information received by, or requiring action on behalf of clients
🔍 About the Role
In this role, you will:
- Act as part of PS & RM Team in line with the scope of the project to meet project outcomes and deliverables ensuring compliance.
- Work within the systems and processes designed to meet Good Pharmacovigilance Practices (GVP).
- Ensure that all potential adverse events or product complaints associated with adverse events, are appropriately reported and followed up according to client procedures.
- Evaluate adverse events & follow up reports received from various channels and assesses seriousness based on criteria.
- Process & report safety data as per SOP and client instructions to maintain client and regulatory compliance.
- Maintain the integrity of client safety data registered into the safety databases.
- Participate in internal and external audits.
- Perform literature surveillance and regulatory authority adverse event searches.
- Assist the Project Manager or the Patient Safety Manager/ Senior Manager as requested (e.g. to provide input to SOPs or Safety Data Exchange Agreements).
🎯 What You Bring
- Health Science degree or equivalent.
- At least 12 months’ experience in a drug safety or equivalent role in a highly regulated industry e.g., pharmaceutical or devices.
- Good working knowledge of the regulatory requirements for managing and reporting adverse events in Japan.
- Understanding of the applicable Australia, New Zealand and EU requirements
- Highly developed service, communication, organisational and problem-solving skills.
- High level of attention to detail and computer literacy with experience in safety database.
- Practical experience in SOP writing and document management.
🌱 Why Join Us?
- Collaborate with some of the brightest minds in pharmacovigilance
- Contribute to projects that have real-world impact on patient care
- Enjoy a flexible, hybrid work model and commitment to work-life balance
- Join a company that values expertise, purpose, and progress
Ready to make a bigger impact?
Click Apply Now and make an impact in pharmacovigilance across JAPAC