YUGENDHAR THATIPAMULA

Responsibilities:

• Daily, crafted a detailed workflow tracking sheet and assigned 300+ ICSR reports for data entry and quality review, meticulously meeting specified due dates
• Created daily workflow plans, optimizing resource allocation and inventory management
• Assigned essential and supplementary tasks as required to enhance overall efficiency
• Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures and assume accountability for the deliverables
• Function as a Point of Contact for the delivery team for regulatory updates, quality concepts, applicable procedures, practices and conventions on the assigned projects
• Work with individuals in identifying training needs based on quality review findings
• Work with other team members to analyze Quality findings and help develop action plan to address them
• Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Manager

Miscellaneous:

• Served as a Subject Matter Expert (SME) for safety database automation and the development of new databases
• Actively participated in activities such as Day in the Life (DITL) testing, User Acceptance Testing (UAT), and Dry Run testing
• Created testing scripts for Dry Run testing, encompassing two distinct databases
• Collaborated with various teams, including the medical review team, finance team, project managers, compliance/QA team, and project training manager
• Interacted with client license partner companies, client SMEs, Pharmacovigilance Vendor managers, IT professionals, and safety database development teams to ensure seamless operations and project success.

• Mentored 30+ associates for data entry and quality review roles, nurturing a highly capable and motivated team
• Trend analysis done for internal and external quality issues and identified field based and error type-based trends which helped improve team quality and saved 2 candidates from expulsion
• Corrections POC, where internal and external case corrections were handled and performed after discussion and finalization
• Triage Review/Individual case safety reports (ICSRs) from the spontaneous, literature, regulatory and clinical trial cases
• Review of audit and inspection requests
• Review of SOP/WI and SDEA sections as applicable
• Prepare procedural documents (SOPs and WIs, Data entry Argus Manual)
• Providing feedback to respective stake holders based on trending analysis observed in quality check to ensure compliance
• CAPA drafting based on the deviations arise through identified non-conformance

Regulatory submission of ICSRs:

• USFDA, EMA, MHRA, TGA, PvPI, Health Canada and MOH (Russia)
• Developing submission QC checklist
• Monitoring team and timely submission of ICSR to regulatory authorities
• Regulatory compliance monitoring

• Complete processing of ICSR's which included case book-in, triage, data entry and narrative writing of all ICSRS
• Quality review of completed cases, achieved consistently 98% accuracy whilst adhering to regulatory requirements.
• Identify clinically relevant information that may be missing from case reports and facilitate its collection, if needed, by preparing follow-up requests in consultation with medical staff.
• Assessed case reports for seriousness, severity and causality assessments, and generate SUSAR reports when
  necessary. Developed narrative.
• Streamlined operations by adeptly coding medical terms and evaluating causality through precise utilization of
  MedDRA and CCDS.
• Monitored and triaged the PVO mailbox, escalating if emails were not actioned within timeline (POC for PVO Mailbox)
• Handled CSR Team (Corporate Social Responsibility).

• Skillfully managed the receipt and processing of solicited and unsolicited AEs and SAEs reports, meticulously adhering
  to guidelines
• Performed initial checks on incoming adverse event case reports, ensuring completeness, legibility, and ensure scientific rigor by accurately, completely, and consistently entering adverse event data from source documents into the Safety Database.
• Suspect products and concomitant medications coding using Company and WHO Drug Dictionary respectively; coded medical history, product indications and adverse event terms using MedDRA; determined listedness of adverse events using appropriate reference safety documents
• Accountable for performing the appropriate clinical assessments (including the assessment of seriousness, labeling and company causality for each adverse event) adhering to SOPs/other controlled documents and regulatory requirements
• Instructed staff during fire drills, communicating evacuation routes and proper reporting techniques.