What you will do

1. Considering impact on subject/patient safety and product value maximization from development to post-marketing stage.

2. Flexible mindset and refined negotiation skill to achieve challenging targets.

3. Act as Product Safety Lead with responsibility for risk management activities as below for Santen investigational and post-marketing products.

• Preparation of signal assessment documents
• Creation of action plans to mitigate/manage product risks
• Development and maintenance of product Core Risk Management Plans (cRMP) and Company Core Safety Information (CCSI)
• Preparation of aggregate safety report such as PSUR
• Development of clinical trial relevant documents such as DSUR, safety management plan, periodic risk monitoring of investigational products
• Leading preparation for safety relevant documents for NDA/MAA dossier in collaboration with other SV members an...