[Singapore] Global Safety Vigilance Risk Management Lead job opportunity at Santen.

Home Jobs In Singapore Tag: Job [Singapore] Global Safety Vigilance Risk Management Lead position at Santen


Date2026-03-27T08:53:10.304Z bot
Santen [Singapore] Global Safety Vigilance Risk Management Lead
Experience: General
Pattern: Full-time
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degreeGeneral
loacation Singapore, Singapore
loacation Singapore....Singapore
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Job DescriptionWhat you will do1. 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 documentsCreation of action plans to mitigate/manage product risksDevelopment and maintenance of product Core Risk Management Plans (cRMP) and Company Core Safety Information (CCSI)Preparation of aggregate safety report such as PSURDevelopment of clinical trial relevant documents such as DSUR, safety management plan, periodic risk monitoring of investigational productsLeading preparation for safety relevant documents for NDA/MAA dossier in collaboration with other SV members and relevant stakeholders with deep understanding for requirements and requests in the applied country as well as submitted dossier and communication with the health authorities in other regions/countries referenced by the applied country.Contribute to R&D project as a representative of SV with scientific and strategic input4. In addition, provides support to SV related activities/projects globally according to the direction made by head  of Medical Evaluation and Risk management at any given time.

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