Jyothi Sharmila Veeravalli

• Performed triage and classification of Individual Case Safety Reports (ICSRs) for report type, seriousness, causality, expectedness/labeling, and reporting, prioritizing ICSR according to regulatory requirements.

• Reviewed and coded adverse events, medical history, laboratory data, and drugs using appropriate event term selection in MedDRA and WHO-Drug dictionaries.

• Reviewed the case narratives for ICSRs for both clinical and post-marketing cases, as per the company's narrative template.

• Processed collected data as per applicable standards, regulations, and guidelines. Conducted data validation, i.e., cross-checking against source documentation.

• Requested all pertinent follow-up information from reporters for the completion of case reports within specific timelines as prescribed by global regulations and SOPs.

• Assisted in the preparation of aggregate reports, including Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs), in accordance with regulatory requirements.

• Reviewed Product Quality Complaint (PQC) cases and collaborated with Clinical Research Organization for Serious Adverse Events (SAEs) reconciliation.

• Assisted with data lock reconciliations and ensured that all cases are completed.

• Filed PQCs (Product Quality Complaints) associated with adverse events.

• Conducted safety data analysis and signal detection activities, contributing to the assessment of potential safety concerns.

• Initiated corrective and preventive action (CAPA) measures following a review of root cause analysis with senior drug safety personnel.

• Acted as Subject Matter Expert (SME) concerning case processing issues and effectively mentored and developed newly hired colleagues/contractors, providing detailed training.

• Consistently met quality requirements and exceeded productivity expectations.

• Processed special case scenarios such as pregnancy, drug administration errors, off-label use cases, and social media cases.

• Performed quality control activities, including the review of source documents and case data to verify accuracy and consistency, as well as to ensure compliance with timelines and quality standards.

• Participated in Serious Adverse Event (SAE) reconciliation activities with SAE information in the clinical trial database.

• Ensured compliance and maintained quality while appropriately escalating and resolving issues.

• Conducted comprehensive literature searches using various databases (PubMed, Embase, Medline) to identify relevant articles related to drug safety and adverse events.

• Screened and reviewed literature articles for inclusion in safety signal detection, risk assessment, and benefit-risk evaluations.

• Systematically monitored these databases for publications worldwide and intrinsically monitored all the active substances for which the organization holds Marketing Authorizations.

• Monitored articles published locally in each territory where the product is marketed and sent translation requests for foreign language articles.

• Routed the obtained results to the appropriate departments within the company to comprehend and comply with the time deadlines that apply to Individual Case Safety Reports Literature Screening.

• Assessed case reports for case validation, seriousness, causality, and expectedness.

• Performed case processing of serious adverse events received from clinical trials, according to the workflow processes and standard operating procedures, and generated accurate and complete case narratives based on information received as part of source documents.

• Monitored electronic mailboxes to ensure timely acceptance of Adverse Event (AE) Reports and performed data entry into databases, as needed.

• Processed literature cases as needed and maintained a literature report spreadsheet.

• Attended project team meetings and provided feedback to the operations manager on any challenges/issues or successes.

• Completed training relating to relevant Pharmacovigilance (PV) Agreements for assigned products.

• Participated in designated activities to support the revision/creation of case processing procedural documents.

• Participated in inspections and audits as identified, including interviews and provision of requested data.

• Reported deviations and implemented Corrective and Preventive Actions (CAPAs).

• Provided flexibility and availability during high inflow of cases to ensure processing and submission of cases within the timelines.

• Coordinated the daily responsibilities and workload of the team by deploying resources and delegating appropriately and equitably to meet short-term and long-term goals defined for adverse event processing.