Yellanki Rajamohan

About Yellanki Rajamohan

RESPONSIBILITIES: Computer system validation (CSV) in accordance with GAMP Guidelines, 21 CFR Part 11, Part 211 & 820 and GxP Regulations focusing on maximizing customer satisfaction, process compliance and software quality in the IT, Life-sciences specially in Pharmacovigillance, Pharmaceutical sectors. Highly proficient with all the phases of SDLC (System Development Life Cycle) process, validation methodologies and concepts of qualification protocols (IQ/OQ/PQ). Experience in development/ review of Gap Analysis, Remediation Plan, Change Control Management, Risk Assessment and validation documentation like Validation Plan, User Requirements Specification, Qualification Plans, Validation Summary Report, Traceability Matrix, IQ/OQ/PQ Test Protocols, etc. Experience in participating internal quality audits, vendor audits and also providing support during audits by external auditors in validation perspective. Good exposure in Requirements understanding and analyzing. Performed administrative activities such as Backup and Restore, Create/Modify/Delete the user access and preparing SOPs for the stand alone and enterprise software. Manually testing the RPA developed tool in development environment in order to proof the defect and discussing the same issue with technology teams so that it gets rectified. Performing computer system validations to newly developed automated tools. Providing technical and regulatory assessment for RPA Process for Pharma domain. Preparation of validation documents for RPA process as per the regulatory requirement. Performing Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) to ensure the tool is deployable into the project. JOB RESPONSIBILITY IN PHARMACOVIGILANCE: Responsibilities for case processing as per related SOP work document, Sponsor reference document etc. Responsible for case processing of adverse events ICSR in ARGUS databases. Responsible to enter the data as per the source documents which is relevant to identifiable patient, Reporter information, Suspect adverse event and Suspect drug. Ensure scientific rigor through accurate, complete and consistent data entry of adverse event (serious & non serious AE) reports from source documents with emphasis on timeliness and quality. Use medical dictionaries Med DRA and WHO DD Dictionary to code data related to medical history, drug indications, adverse event terms and appropriate selection of drugs name. Responsible for case narratives writing and summarizing the essential details of the case.

Experience

1. Computer System Validation

   Cognizant

   Jun 2022 — Present

Education

• Vageswari Institute of Pharmaceutical Sciences

  D.Pharmacy

  2004 — 2006

• Siddartha High School

  SSC

  2002 — 2002

• St Peters Institute of Pharmaceutical Sciences

  B.pharmacy

  2006 — 2010

• Intermediate

  Intermediate

  2002 — 2004

Skills

• Clinical Trials
• Pharmacovigilance
• Management
• CRO
• Pharmaceutical Industry
• Gcp
• Oncology
• Clinical Development
• Life Sciences
• Clinical Research