Lavanya Burugu

• Case processing for all types of cases reports like solicited, spontaneous, literature, clinical study etc.

• Case receipt, validity check and duplicate search, book-in and registration of case in respective safety database.

• Systematic literature screening, validity check, identifying potential adverse events in accordance with regulatory guidelines.

• Data entry of ICSRs in the safety database.

• Strong Knowledge on coding of all medical history, events, drugs using MedDRA, WHO-DD.

• Determining the expectedness of adverse events against various labelling documents (such as SmPC, CDS, IB etc.), writing case summaries, case narrative, assessing causalities.

• Actively involved in handling pregnancy exposure cases ensuring timely follow-ups.

• Handling medical device cases includes device-related events, product complaints alignment with global regulations.

• Adhering to pharmacovigilance activities assigned by respective Manager/Team lead.

• Performing reconciliation activities.

• Handling of critical safety case related queries involving missing or conflicting information.

• Collaborated with cross-functional teams for query resolution and process improvement.

• Conducted literature searches, screening, and validity assessments.
• Processed and reviewed Individual Case Safety Reports (ICSRs) ensuring compliance with global regulatory requirements.
• Performed quality checks (QC) on safety data to ensure accuracy, completeness, and consistency.
• Prepared submission-ready documents and supported responses to regulatory queries.
• Demonstrated strong medical writing by translating complex data into clear, concise, and compliant narratives.
• Supported data entry, validation, and reconciliation activities aligned with clinical data workflows
• Ensured compliance with global regulatory requirements and timelines.
• Reviewed ICSRs and analyzed adverse event trends contributing to aggregate safety evaluations.
• Review source documents attached to the ICSR of the assigned cases by viewing and reviewing all the data entered in the ICSR and adding the missing information based on the source documents.
• Perform daily responsibilities in accordance with all applicable procedure documents, conventions and client policies.
• Work with the safety review team lead or manager to escalate issues or tasks outside the normal scope of work.
• Contributed to the preparation of safety documents, including narratives and aggregate reports (e.g., PSURs/DSURs).
• Trained in Aggregate Reporting including PSUR and PBRER drafting
• Basic knowledge of PSUR/PBRER preparation and pharmacovigilance aggregate reports
• Familiar with aggregate safety report drafting (PSUR, PBRER)