Dipti Kadam Email & Phone Number

• Certified Argus Safety Suite 7.0 Implementation Specialist.• Functional Consultant in Pharmacovigilance with 14+ years of work experience in Clinical Research.• Trained in ICH GCP and familiar with FDA and EU regulations – ICH E2A to E2F guidelines, EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines - Annex 11 Computerised Systems, Good Pharmacovigilance practices (GVP) module I and VI. Familiar with FDA Regional Technical Specifications for ICH E2B (R3) and ICH E2B(R3) IWG Implementation: Electronic Transmission of Individual Case Safety Reports.• Oracle Argus Safety, ARISg, Oracle AERS Safety Systems. • Efficiently handled Safety Data Review/Management, SAE Reconciliation activities in various therapeutic areas and vaccines. • Successfully managed Processing of Individual Case Safety Report (ICSRs), preparation of safety documents, aggregate reports, SOP development.• Effectively managed working on Request for proposal of Drug Safety/Pharmacovigilance for clients and also SAEs, SUSARs processing, narrative generation and assisted team in Regulatory submissions.• Worked on more than 10 projects of Argus implementation and hosting of clinical system as functional consultant. • Capably managed assisting project management of implementation of Data Management, Drug Safety, Clinical monitoring and Finance systems. • Safety system business analysis during implementation and conducted validation activities, documentation of Oracle Health Sciences applications.

Listed skills include Clinical Data Management, Pharmacovigilance, Clinical Trials, 21 Cfr Part 11, and 1 others.

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  University Of Mumbai

  Plant Biotechnology