
Associate - Safety Operations
1 week ago
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Key responsibilities:
Provide operational support for following, but not limited to, pharmacovigilance and observational study related activities
- Safety management activities related to Lilly’s investigational products and devices during development phase - DSUR development, RMP development, Post launch RMP materials development, Query responses, etc.
- Safety management activities related to Lilly’s products and medical devices in the post-launch phase - RMP maintenance, Safety material development and maintenance, Safety report development,
- Safety Central Capability activities - Support to Safety Responsible Manager in Japan (An-Seki, Seihan-Seki), EPPV management, Safety information provision to customers (Den-Tatsu), TPO management, etc.
- Clinical Case Management - Operational support for all of case management activities (e.g. case receipt, case processing, metrics, data handling etc.) in development and post launch phase
- Evidence Creation - Operational support for PMSS and observational studies (e.g. protocol development support, other study document development such as ICF/training materials, study team meeting support, GPSP inspection support, etc.)
**Requirements**:
- Bachelor’s degree in pharmaceutical/life science or any other healthcare related field or equivalent experience.-
- Good verbal (conversational level) and written communication in Japanese.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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