Kiran Shivaji Bande

Roles and Responsibilities:

• Experienced in working on safety databases ARGUS and MedDRA.
• Remarkable knowledge to monitor and track serious adverse events, serious and non-serious adverse drug reactions, causality, expectedness, and other medical-related project information.
• Identification of the source of the source document, checking the validity of the case, and performing the duplicate search.
• Coded all types of cases, including solicited, spontaneous cases, clinical trial cases, as well as special situation cases like missed dose, off-label use, drug misuse, drug abuse, overdose, and medication error.
• Performing data entry, triage, which includes coding of medical history, historical drugs, laboratory data, concomitant medications, and discharge summaries of the patient.
• Writing reasons for lateness and CAPA for late cases.
• Actively provided medical and pharmacovigilance knowledge to the other part of system automation.

Quality Reviewer – Pharmacovigilance.

• Conducting quality reviews of Individual Case Safety Reports (ICSRs) to ensure accuracy, completeness, and compliance with regulatory requirements.
• Reviewing serious and non-serious adverse event cases, ensuring proper assessment of causality, expectedness, and medical relevance.
• Verifying the accuracy of data entry, including medical history, concomitant medications, laboratory data, and coding using MedDRA.
• Identifying discrepancies, errors, and inconsistencies in case processing, and providing corrective feedback to case processors.
• Ensuring adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and company-specific requirements.
• Performing duplicate checks and validating source documents to confirm case legitimacy.
• Reviewing and approving reasons for case delays, and assisting in the creation of Corrective and Preventive Actions (CAPA) for compliance improvement.

Roles and Responsibilities:

• Experienced in working on the safety database, ARGUS.
• Triaging and intake of Individual Case Safety Reports (ICSRs).
• Case Types Handled: Spontaneous, Post-Marketing Surveillance (PMS).
• Booked-in/intake and triaged Individual Case Safety Reports (ICSRs) in safety databases and automated tools.
• Advanced the skills in medical terminology and MedDRA coding using the ARGUS safety database.
• Doing self-quality reviews to ensure accuracy and consistency in data entry and reporting.
• Redaction is being performed to ensure patient confidentiality.

Roles & Responsibilities:

• Data entry of individual case safety reports into the ArisG database.
• Handled various ICSR report types, including Spontaneous, NIP/MAP, NIS, CT, SUSAR, and Non-SUSAR, HA and special situation cases.
• Full data entry, including narrative writing and distribution of own cases.
• Prioritizes coding all medical history, indications, and lab tests according to the appropriate dictionary (MedDRA, Company Product Dictionary, WHO-DD).
• Assuring and maintaining compliance with regulatory timelines, proactive workflow management.
• Writing reasons for lateness and CAPA for late cases. Actively provided medical and pharmacovigilance knowledge to the other part of system automation.
• Guidance and Training: Mentored and trained new team members on data entry, case processing, and compliance requirements in pharmacovigilance using ArisG.