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.
• 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)

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.

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