SUSHMA SINGH

Processed Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs) within specified timelines.

Maintained adverse event tracking systems to ensure accurate logging of reports.

Generated queries for missing information in consultation with medical staff when necessary.

Submitted expedited Serious Adverse Event (SAE) reports to clients and regulatory authorities as required.

Trained and mentored PSS Assistants on daily operational tasks.

Conducted peer reviews of processed reports to identify trends and implement corrective actions.

Coordinated safety study files for project completion and archiving purposes.

Ensured compliance with regulatory requirements and departmental Standard Operating Procedures.

Evaluated abstracts, citations, and full publications for literature review tasks.

Identified event terms, assessed causality and seriousness against client SOPs.

Validated suspect products, including biosimilars and active moieties, within citations.

Ordered retrieval of full publications for cases derived from abstracts.

Processed Individual Case Safety Reports (ICSRs) for regulatory authorities and clinical trials.

Performed medical coding of history, events, drugs, and tests using designated dictionaries.

Generated accurate narratives with comprehensive details on adverse events.

Mentored associates on project-related queries to enhance team performance.