ASHVINI SAXENA

• Ensure compliance with the client-specific SOPs/policies and any updates related to Pharmacovigilance or patient-based set of rules provided by the client.
• Receive literature citations through EMBASE, review the full-text abstract to check the validity of the case, and report the valid cases through the safety portal.
• Execute drug safety data management processes – a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation, policy compliance, and submission to regulatory authorities.
• Identifying and tracking errors in the cases.
• Managing global mailbox activity which includes identifying the type of correction, assigning corrections to the respective groups, and connecting with clients to receive new updates.
• Prepare and share daily EOD status with the team.
• Implement consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures.

• Perform processing of adjudication events.
• Maintaining event tracking systems.
• Event case processing: intake and triage, event linking, event deactivation, tracking, data entry, document processing which includes redaction of specific content, review of incoming event information for completeness and accuracy, content review, identification of missing required data or documents, generation of queries, query review and closure/re-issue.
• Contacting site personnel to obtain missing data and documents.
• Escalating open events for issue resolution and closure, under relevant Escalation Plan.
• Completing first review QC checklist and assembling dossiers.
• Conducting event reconciliation processes.

• To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events (AE)/endpoint information; determining initial/update status of incoming events; database entry; coding AE and Products, writing narratives, assisting with reconciliation, case closure related activities, as per internal/ project timelines.
• Provide project-specific operational process training to new team members as appropriate.
• Participate in team meetings and provide regular feedback on regular updates from clients and internal updates to team members.
• Conducting training sessions for team members.

• Performing duplicate searches, booking the case into the Client's corporate safety database and attaching the Source Document form to the case and then routing the case appropriately in the next workflow.
• Narrative writing which includes case summary, medical history, concurrent conditions, study medication, event occurrence, action taken with the drug and outcome of the event.
• Coding of suspect products using ICDS and concomitant products using WHO dictionaries and events, medical history, and laboratory tests using MedDRA dictionary.

Major Achievements:

• Received Star Business Award for learning and certification.
• Certified for handling pregnancy cases and joined the Hyper care team.
• Enhanced delivery performance by focusing on areas requiring improvement, leading to 100% on-time performance.