Arjun Boraste Email & Phone Number

Pune, Maharashtra, India

• Promptly and accurately identify, interpret, and extract adverse event and all relevant adverse event and all relevant corresponding case information from wide variety of source documents including post-marketing and clinical trial source documents.• Enter the extracted information into the global database for serious and non- serious AE/ADR case reports• Identify information such as product technical complaint in the source document, which must be further processed by the local affiliate, and forward accordingly.• Adhere to Projects internal data entry standards and specific timeline as prescribed by global regulations and SOPs.• Create and review comprehensive medical case narrative with no important gaps regarding the reported information received.• Verify as described by regulatory guidelines that trade names are correctly translated into INN (International Non-Proprietary Name)• Perform accurate coding of incoming serious and non- serious adverse events and other case information using MedDRA terminology.• Perform assessment of case regarding the global listedness.• Enter drug-event relationship in non- serious and serious expected ADR/AE case report as per company policy.• Ensure medical plausibility consistency and completeness of ADR case report and appropriate case level status regarding regulatory agency reporting.• Request follow up information for the completion of case reports, making use of specific product/event-related questionnaires when necessary. Consult medical experts within TA group for advice in clinical questions.• Contribute to a continuous improvement of PV system and process.• Identify quality issue related to source document and data entry, need alignment in processes that require immediate escalation.• Perform case deletion according to the process described in the argus user manual/ Applicable QSDs.• Support training and mentoring activities as requested and serve as a mentor for new PV case processors as and if needed.

Mysore, Karnataka, India

As Quality Check Reviewer:• Reviewed data entered in safety database for completeness and accuracy. • Provided quality feedback to team resources. • Tracked and maintained quality metricsAs Case Processor:• Responsible for data entry of Individual case safety reports into the safety database. • Reviewed and evaluated AE case information to determine required action based on and following internal policies and procedures. • Processed all incoming cases in order to meet timelines. Achieved Full data entry including medical coding and safety narrative.As Medical Coder• Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g., MedDRA, Company Product Dictionary, WHO-DD) in Safety Database.As Narrative Writer • Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.Other responsibilities: • Following up with sites regarding outstanding queries. • Followed up on reconciliation of discrepancies. • Followed departmental AE workflow procedures.• Closure and deletion of cases. • Mentored and guided the activities of the Dug Safety Associate. • High level of proficiency all-workflow tasks. • Performed other drug safety related activities as assigned by Supervisor.Secondary Responsibilities • Maintained quality service and departmental standards by Reading, understanding, and adhering to organizational standard operating procedures (SOPs) • Assisting in establishing and enforcing departmental standards.• Contributed to team effort by Working with internal staff to resolve issues. • Guided others to achieve results. • Performed other duties as assigned Maintained technical and industry knowledge by: Attending and participating in applicable company-sponsored training.

Pune, Maharashtra, India

• Practical hands on ARISg and AgXchange database: Triage, Data entry, Case processing, MedDRA coding, WHO drug coding, SAE narrative writing, case follow up. • Worked in 3 different projects for the organization during the period consisting of Case Intake, Case Triage and Case Processing. • Understanding of drug development processes including drug safety and different phases of Clinical Trials. • Implemented and promoted use of consistent, efficient and quality process to meet timeline. Ensured compliance of operation. • Detailed Knowledge of clinical trial process, literature cases, post marketed study cases and Spontaneous cases. • Undertook and completed additional tasks/activities assigned by supervisor as required.

Master Of Science In Process Validation And Regulatory Affairs, Pharmaceutical Sciences

Masters In Pharmacy, Industrial Pharmacy, Distinction

Bachelor Of Pharmacy - Bpharm, Pharmacy, First Class