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Patient Safety Associate 337
ProductLife GroupTokyo, Japan11 days ago
Job descriptionHealth 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. 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
Group 10
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
Why Join Us?
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Associate • Tokyo, Japan