Ekta Adsule

• ⁠Managed Individual Case Safety Reports of all case types (serious and non - serious cases from spontaneous and solicited programs, literature and E2B cases, which included: Triage of Confidential to determine whether they qualify for expedited reporting or not and the timelines within which they need to be submitted to the regulatory authorities
• Conducting duplicate searches prior to initiation and identifying potential duplicates.
• Initiating/Registering of Confidential into the satety database.
• Trained junior staff on pharmacovigilance regulations and best practices.

• As Case Processor:
• Duplicate/Invalid ICSR Handling: Identifying duplicate or invalid Individual Case Safety Reports (ICSRs) and managing them according to SOPs.
• Adverse Event Processing: Reviewing, assessing, triaging, processing, and reporting adverse event reports within regulatory timelines, adhering to safety guidelines.
• Diverse Report Processing: Handling clinical trials, Licensing partner (LP), Legal, Listing/Aggregate, and Literature reports (both Expedited and Non-Expedited) from various sources like Jasper, E2Bs, articles, and clinical databases.
• Source Document Review: Assessing source documents and evaluating seriousness, case validation, causality, and expectedness for triaging and categorization. Special Scenario Analysis: Analyzing AE reports involving special scenarios like medication errors, overdoses, and pregnancy cases and processing them accordingly.
• Data Entry and Coding: Performing end-to-end data entry, including coding of medical terminology, concomitant medications, and relevant medical details using MedDRA and WHO-DD.
• Narrative Writing: Crafting descriptive narratives for applicable ICSRs.
• Timely Case Closure: Ensuring timely closure of cases.

As a Quality Reviewer and Mentor:

• Risk Mitigation: Minimizing risk through active collaboration with Quality Standards and engaging with management when necessary.
• Training and Mentorship: Conducting training sessions for new associates and acting as a mentor within the team.
• Quality Evaluation: Performing thorough quality reviews and discrepancy analyses across critical domains, including narrative composition and patient safety details.
• Analyzed patient safety data to identify trends and areas for improvement.
• Developed and implemented safety protocols for clinical processes and procedures.
• Collaborated with healthcare teams to enhance patient safety initiatives.
• Conducted regular training sessions on safety standards for staff members.
• Managed incident reporting system to ensure timely documentation and review.
• Tracked progress made towards meeting goals set by the organization in regards to improving patient safety measures.

• Processing of all clinical, spontaneous, non interventional cases.
• Handled Quality reviewer's position and performed a quality check of ICSR, processed by case processor for accuracy and completeness (Argus database)