Dr. AASHISH PATWARDHAN

Summary of Work: Worked as Triager and Data entry of Individual Case Safety Reports (ICSR) from different type of sources mainly of contrast agent reports including article review and responsible for processing valid and invalid safety signal cases in Arisg Database.

• Case management activities which includes; receipt of cases, entry in case activity tracker, FUP ADR tracker (MQT), triaging ICSRs.
• Data Entry of ICSRs in Pharmacovigilance database which includes; Duplicate check, Entering source data in the database, MedDRA Coding, Narrative writing, Labeling of events, Report scheduling (if applicable), Attachment of source document in database.
• Screening, evaluation and review of literature articles for identification of valid/potential ICSRs for processing.
• Receipt and evaluation of safety data exchange agreements (as applicable) for sharing and other obligations.
• Builds and maintains good relationships across functional units and company affiliates.
• Escalate critical calls to concerned managers/clients.
• Remain up-to-date with the latest information on the assigned product(s).
• To carry out necessary administrative duties required for the job.

Summary of Work: Worked as data entry and handled data entry of all type of Individual Case Safety Reports (ICSR) and responsible for processing valid and invalid safety signal cases in Argus database.

Roles and responsibilities as a Data Entry –.

• Responsible for data entry and code, as applicable, case data including but not limited to event, seriousness, causality, medical history and laboratory data as provided by the reporter.
• Responsible for coding products specified as suspect or concomitant by the reporter.
• Responsible for writing the narrative as required.
• Review adverse event report for accuracy, consistency and completeness and verify certain fields determined as critical as well as conformity to E2b standards.
• Initiate follow up activities to obtain additional information and clarification, as appropriate.
• Initiate query action items (split case request and clarification of discrepant case information).
• Initiate Non-Assessed License partner letters as appropriate.

• Participated in Ward Rounds, Patient Counseling & Public Health Centre (PHC).
• Checking Medication Errors, Finding and Reporting Drug interactions.
• Monitoring, Reporting (to PvPi) and Documentation of Adverse Drug Reactions.
• Two Months Posting in Specialty Departments like Cardiology, Surgery and Pediatrics.
• Educated patients on possible drug interactions, potential side effects and optimal methods of administration.
• Discussed medical histories with patients to provide most effective medical advice.