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Strong working knowledge of ARGUS case management and processing; experience in using ARGUS or other safety databases; experience with MedDRA/WHODrug for coding AEs, medical history, and concomitant medications.
$85Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Proficiency with drug safety databases (i.e., Argus), electronic data capture (EDC) systems, Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization (WHO) Drug dictionary coding.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Knowledge and application of commercial coding dictionaries (MedDRA, WHO Drug) years Drug Safety/Pharmacovigilance experience. Contribute to qualitative and quantitative research projects through collaboration with data trends from cross-functional teams (Pharmacovigilance, Epidemiology, etc.
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Clinical data management systems - eCOA, IRT, and industry wide thesauri, such as MedDRA and WHO Drug. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Working knowledge of MedDRA and WHODRUG coding dictionaries. Liaise with commercial partners pharmacovigilance departments to coordinate maintenance of related global safety databases. Working knowledge of MedDRA and WHODRUG coding dictionaries.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Experience with MedDRA coding, safety databases, and clinical trial databases. The DPV works closely with the Global Safety Physician (GSP) and other colleagues within the Medical Risk Management (MRM) team for all deliverables related to benefit-risk management of assigned product(s.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Tasks may include: review of source information, MedDRA coding, narrative preparation, preliminary seriousness, causality and listedness assessments, case corrections, and listing reviews. Support case processing as a SME for MedDRA coding.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Relevant experience in the Gastrointestinal therapeutic and/or rare disease area a plus. The Director of Pharmacovigilance (DPV) leads and/or oversees safety and benefit-risk management for assigned product(s), management of potential safety issues, identification of signals and their evaluation, and other activities such as drafting responses to regulatory inquiries on product safety issues for assigned product(s.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Proficiency in coding dictionaries (MedDRA, WHODRUG). Familiarity with common software and technologies used in clinical data science (e.g., SAS, R, Python, Rave, Veeva). Experience with EHR, eCOA, IRT, and MDR systems is a plus.
$224,000 - $233,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Demonstrate knowledge in research design, system validation, E2B / CDISC, standard coding dictionaries (MedDRA) Develop and maintain systematic criteria and algorithm of selecting adverse event terms for the labelled or expected event and safety signal/risk and make them up to date along with the MedDRA version.
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They will also perform medical review for safety events, provide medical oversight of company causality assessment, and expectedness assessment, review of MedDRA coding, signal detection, and risk management for assigned projects.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA. Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA. Highly-developed scientific and analytical knowledge base and an excellent understanding of good pharmacovigilance practices and current regulations within drug safety.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Experience in triaging of cases, coding of terms using MedDRA, data entry and narrative writing. Eight (8) years of experience in pharmaceutical drug safety/pharmacovigilance case processing including branded and generic products and all case types (spontaneous, clinical trial and litigation.
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Strong understanding of the application of MedDRA and WHO Drug clinical data coding classification systems. Ensure DM project deliverables are completed on time and in accordance with quality standards and regulatory requirements from study start-up through study closure/archival.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Good understanding of database and dictionary structures (e.g., MedDRA) Working understanding of GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices.
$110,000 - $150,000ExpandApply NowActive JobUpdated 4 days ago
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