Anil Naik Bhukya

· Proficiently author and ensure the quality of diverse Aggregate Safety Reports (including PBRER, PSUR, PADER, AdCO, Ad Hoc reports, Signal Assessment reports, Case Safety reviews, Literature review for monthly activity,Signal frequency reports analysis, HA.

Peer review the cases by evaluating accuracy, consistency, and completeness of data entered in the safety database against the source document, and to check the consistency between narrative and database fields, and ensuring the reason for any delay entered in the routing comment.

· Resolving the validation errors triggered in the ICSR process.

· Review of ICSRs and correct the data entry errors, if any, prior routing them to regulatory authorities for submission. Process all incoming cases in order to meet timelines.

· Maintain the allocation and productivity tracker.

· Taken care of DLP cases to be locked on time in order to generation of Line listing of particular drug.

· Full data entry review including medical coding and safety narrative.

· Responsible for coding all medical history, events, drugs/procedures/indication and laboratory tests according to the appropriate dictionary (ex: MedRA, Company Product Dictionary, WHO-DD).

· Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the date entered in the various fields.

· Review data entered in safety database for completeness and accuracy.

· Provide quality feedback to team resources.

· Responsible for data entry of individual case safety reports into the safety database.

· Review and evaluate AE case information to determine required action based on and following internal policies and procedures.

· Responsible for case intake, data entry, duplicate search, initial seriousness assessment and setting disposition

· Review and evaluate adverse event information to determine required actions based on internal policy and procedures

· Full data entry including medical coding (coding medical history/events/drugs/procedures/indications and lab tests according to appropriate dictionary) and safety narrative

· Review of managers daily reports to ensure compliance and prioritization of cases in daily workflow to meet the PVA and regulatory timelines

· Deep dive analysis of duplicate search errors

· Handling operations mailbox and acknowledgment mailbox

· Perform accurate data entry of case reports, duplicate search, initial seriousness assessment, review and evaluate adverse event information to determine required actions based on internal policy and procedures into the safety data base and tracking system

· Promptly request follow-up in formation and proficiently manage queries

· Skillfully code data within the safety database, ensuring accuracy and consistency

· Actively participate in internal, drug safety, and project-specific training sessions

· Ensure timely and accurate data entry of adverse event reports from source documents, maintaining high standards of quality and adherence to established timelines