Senior Manager, Global Patient Safety
R
Regeneron Pharmaceuticals
📍 Minato-Ku, Japan, Japan
Job Description
**Position Overview**
Our mission is to safeguard patient safety and lead pharmacovigilance (PV) in Japan.
The Senior Manager, Global Patient Safety (GPS) reports to the Director, GPS (Safety Management Officer) in Japan and serves as a core leader for safety operations, overseeing the handling of Individual Case Safety Reports (ICSR), Investigation Reports (RR), and Foreign Measures Taken (FSMT) reports. Additionally, this role proactively drives aggregate reporting, vendor management, and GVP-related activities to ensure both quality and compliance.
**What Makes This Role Attractive**
+ Make meaningful impact in a high-stakes safety function as a key member driving Japan’s PV framework
+ Lead vendors and cross-functional teams to design and implement process improvements
+ Contribute to pivotal documents directly linked to development and post-approval, including J-RMP and J-NDA
+ Collaborate globally and gain experience bridging internati...
Our mission is to safeguard patient safety and lead pharmacovigilance (PV) in Japan.
The Senior Manager, Global Patient Safety (GPS) reports to the Director, GPS (Safety Management Officer) in Japan and serves as a core leader for safety operations, overseeing the handling of Individual Case Safety Reports (ICSR), Investigation Reports (RR), and Foreign Measures Taken (FSMT) reports. Additionally, this role proactively drives aggregate reporting, vendor management, and GVP-related activities to ensure both quality and compliance.
**What Makes This Role Attractive**
+ Make meaningful impact in a high-stakes safety function as a key member driving Japan’s PV framework
+ Lead vendors and cross-functional teams to design and implement process improvements
+ Contribute to pivotal documents directly linked to development and post-approval, including J-RMP and J-NDA
+ Collaborate globally and gain experience bridging internati...