SHRUTI ZACHARIAS

• Develop competence of factory and quality associates as necessary
• Promote quality awareness and foster strong commitment to quality across unit
• Define and update specific Quality procedures, instructions, and tools within area of expertise
• Contribute to defining and monitoring quality Key Performance Indicators
• Collaborate with QA Manager to set operational objectives
• Support Nestlé Continuous Excellence program in quest for zero defects
• Support unit readiness for internal and external audits
• Assist in troubleshooting and following up on non-conformities.

• Supporting Senior Scientist, Senior Analyst and Associate Director, Scientist in their activities during study start-up activities by generating/managing documents according to applicable procedures/best practices, set up/configuration of applicable tools
• Review of patient-level clinical/safety data on ongoing basis to ensure medical accuracy and completeness, coding consistency and generate applicable queries as needed to obtain information for appropriate medical assessment and case closure
• Schedule and facilitate different types of meetings, creating visualizations from applicable tools and prepare slides/reports/data as required, Perform quality check of documents and file TRISARC (Trial Safety Review Centre) documents in eTMF other activities.
• Developed innovative research methodologies for improved data collection and analysis.
• Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation.

• Processed on all types of cases including spontaneous, literature and post marketing study case types
• Assisting new team members on client specific conventions and on safety database ISS
• (Argus), Perform QC review of Individual Case Safety Reports (ICSRs), literature screening for valid ICSR and non-valid case reports, and meet quality standards as per requirement
• Accountable for recognizing, processing, and reporting Product Quality Complaints (PQC) information as per applicable SOP and WI
• Coding terms as per MedDRA guidelines, Identify SAEs, LOE, Pregnancy case and PQC only case and inform team leads and Ensure integrity and completeness of data according to applicable regulations and guidelines, SOPs, and project−specific guidelines
• Program, GDP (Good Documentation Practices), GCP (Good Clinical Practices), Global PV Regulations, ICH Guidelines and Pharmacovigilance Auditing.
• Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
• Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.

Worked on safety data base ARISg (7.2 version) and AgEncoder other client owned tools and software

• Individual Case Safety Report (ICSR) processing as per applicable Standard Operating Procedures (SOPs) and Work Instructions (WI) including but not limited to Triage, Duplicate Search, Data Entry, MedDRA coding, Narrative Writing, Medical Evaluation, Seriousness assessment, expectedness assessment, Causality assessment, Reportability Assessment, Expedite, and Periodic submission, etc
• Provide Pharmacovigilance expertise to support Pharmacovigilance team on detection, assessment, processing, and reporting of all safety events
• Perform Literature Review as per applicable organization's SOP and WI
• Ensure quality, validity, accuracy, and timely submission of initial and follow-up safety event reports
• Perform quality check (QC) of adverse events/product quality complaints and all other applicable source documents to ensure compliance with PV reporting requirements
• Preparation and submission of reconciliation reports as per PV agreements with suppliers
• Assist in development and oversee implementation of required PV training and education for applicable cross-functional teams, and subcontractors
• Monitor monthly PV KPIs and proactively highlights trends to internal stakeholders for prompt solutioning
• Proactively identify potential risks or gaps and provide risk mitigation strategies
• Provide input in RMP - Risk Management Plans.

• Publications on 'Assessment of medical therapy management as per NICE guidelines' and 'Pharmacoeconomic estimative study in Orthopedic operative cases in tertiary care hospital' published in Orchid research journal for pharmaceutical, biological and chemical sciences (2017-2018).