Harshada Chaudhari

• Responsible for management and timely submission of aggregate report in order to achieve 100% regulatory compliance
• Interact with staff at various levels and in various functional areas to resolve any issues that arise during reviews
• Preparation of data required PSURs, Addendum to Clinical overview summary report, and Risk Management Plan as per companies-controlled documents (e.g
• SOPs, WIs, and Guide) and guidelines
• Handling of the all the queries from regulatory authorities and vendors related to Pharmacovigilance activities, cases processing and submissions
• Perform Data correction, reconciliation and CAPA on deviation, Training and Quality compliance, and suggestion on SOP improvement
• Review of the cases which booked by case triager and assessment of the seriousness of the case and the prioritization of case for submission
• Assist Regulatory Team on new regulatory updates, guidelines or approvals done by regulatory authorities in terms of implication
• Ensure appropriate RCA and CAPA are performed for KPI and SLA targets as applicable
• Providing the status and data related to the approvals, available strengths, dosage form, indications and combination of products and literature related to new or existing products
• Supporting on invoice preparation and follow-up for the received and pending payments and per SOW

• Argus and ArisG database handling and handled Mailbox and its reconciliation
• To perform Quality check of fatal, serious and non-serious cases
• Responsible for QC of case processing and submission guidance in finalized cases from all therapeutic areas
• Responsible for data entry of individual case safety reports into database
• Review and evaluate AE case information to determine validity of a case, seriousness and expectedness and according to prioritization as per the client and internal policies and procedures
• Created, edited draft narratives and follow-up queries based on missing clinically significant information from clinical trial
• Trained and mentored peers in case processing methodologies

• Proficient in use of Argus Safety Database
• Performed case triaging, case processing, Acknowledgement, and Query rising to clients
• Ensured accuracy of coding, which includes selecting appropriate event terms, laboratory test, historical conditions in MedDRA, and worked closely with the coding department
• Ensured scientific rigor through accurate check of complete and consistent data entry of adverse event reports from source documents with emphasis on timeliness and quality
• Reviewed, processed, coded, and submitted serious and non-serious adverse event reports for spontaneous and sponsored studies, in compliance with global regulations and compliance timelines
• Historical drugs, Study drugs, and concomitant drugs coding with CPD and WHODD
• Expert on assessing the appropriate clinical assessments (seriousness, labeling, causality, SUSAR cases review, and medical cohesiveness of narrative) as per client SOPs and regulatory requirements
• Deployed in various verticals of the project Performance linked rewards
• Star performer awards
• Case Tracking Tool used for case workflow to allocate cases appropriately

Proficient in use of Argus Safety Database

Performed case triaging, case processing, Acknowledgement, and Query rising to clients

Ensured accuracy of coding, which included selecting appropriate event terms, laboratory tests, andhistorical conditions in MedDRA, and worked closely with the coding department.

Ensured scientific rigor through the accurate check of complete and consistent data entry of adverse event reports from source documents, with an emphasis on timeliness and quality.

Reviewed, processed, coded, and submitted serious and non-serious adverse event reports for spontaneous and sponsored studies, in compliance with global regulations and compliance timelines.

Historical drugs, study drugs, and concomitant drugs coding with CPD and WHODD.