Drug Safety expert proficient with the latest and upcoming trends in drug safety required for long term advanced safety analytics advisory. An RNA based platform with multiple indications, applying advanced safety analytics to support the entire portfolio, as opposed to only one indication at a time, is a core strategy for the drug sponsor. Expert […]
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Drug Safety Scientist required at 30% of FDA. Must be expert in drug safety statistics. For the particular asset under development the safety profile is extremely strategic. The main competitor product’s safety profile is not ideal but since there are no other treatments it is the primary product for this condition. This asset has similar […]
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Small anti-infectives, US based (northeast) drug sponsor to conduct 2 studies to support a new drug application. Study start up, first patient in target- end of Q1 2022. Primary Responsibilities The primary responsibilities of this role include but are not limited to: Management and oversight of all technical and building-related operations and services, including responsibility […]
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Small, CA based, phase 2 immunology drug sponsor in need of drug safety expertise: Enhanced Pharmacovigilance Plans and REMS programs Signal detection programs and Global Safety Board processes PV Operations support Vendor management support Executing the RFP process for PV and Medical Information vendors PSMF support PV agreement support QC of ICSRs Among other recommendations […]
READ MOREUK based global full service CRO in need of a strong case processing project manager to lead the post marketing case processing team for 4 key clients. Must be an expert on case processing at least 5 years direct experience in post marketing case processing, and familiar/conversant with other PV concepts. Strong leadership and demonstrated […]
READ MORELarge, UK based CRO in need of a contract PM to facilitate a migration of data from one PV system onto the Oracle Cloud. Strong project management required, pharmacovigilance domain expertise also required, familiarity with Oracle Argus, both in-house as well as cloud. Project expects 20 hours a week for 6 months. Must be able […]
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