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Senior Drug Safety Specialist
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- Job Title: Senior Drug Safety Specialist
- Reporting to the Associate Director, Drug Safety and Pharmacovigilance Compliance and Operations, you will play a pivotal role in drug safety activities, supporting records management and compliance across the clinical development and marketing programs.
- Identifies and supports the DSPV team with document management activities (e.g., electronic Trial Master File, Veeva), including maintaining electronic files internally, and collaborate cross- functionally with Client teams, CRO’s and vendors.
- Contribute to the quality management Drug Safety system including: ensuring department standards are met, training requirements, monitoring performance, implementing continuous improvement actions and documentation practices.
- Supports sponsor oversight of AE/SAE processing by outsourced vendors, including the review and monitoring of compliance through various monitoring reports and other oversight activities and ensures the implementation of effective corrective and preventative action plans.
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