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Director, Drug Safety Operations
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- This role is responsible for overseeing all aspects of drug safety study operational activities from study start up to close out.
- Oversight and review of drug safety operations practices.
- Liaise externally with Drug Safety vendor and business partners on case management issues, processes and timelines to meet global regulatory requirements for SAE reporting and other data exchange obligations.
- Develop and/or update SOPs, processes and practices for SAE and other safety data collection in accordance with drug safety and pharmacovigilance regulations, ICH standards and guidelines as appropriate to ensure timely and compliance submissions to worldwide regulatory agencies
- Oversee workload distribution in coordination with Drug Safety Workflow Manager.
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