Smita Patel
- Role
- Senior Safety Specialist at Novavax
- Location
- Wayne, PA, US
- LinkedIn followers
- 500 followers
About Smita Patel
OBJECTIVE: To obtain a position in a challenging, people-oriented, team environment…
Experience
Senior Safety Specialist
Apr 2022 — Present
Provide support to the PV study manager in the operational oversight of CROs performing PV safety activities, including case processing • Initiate urgent follow-up activities to CROs or investigative sites to retrieve missing information, according to AE/SAE reporting requirements, regulatory guidelines, and department SOPs • Track cases processed by CROs or in-house to completion to ensure adherence with established case processing timelines • May serve as lead Safety representative in clinical study team projects • Interact with internal cross-functional leadership or outside of the company • Actively participate in the development and implantation of Safety Management Plans for study-specific workflow • Perform reconciliation of safety data with collaborating Business Partners • Mentor newly hired junior PV team members • Other related administrative responsibilities and duties, as required by business need and/or assigned by manager
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