Namita Singh Email & Phone Number

I have experience in performing Pharmacovigilance activities for pharmaceutical companies, CROs and Health Authorities, along with software expertise and insights required to fulfil compliance requirements in this domain. I have extensive experience in client interfacing and management of projects.Consultancy for IT services in Pharmacovigilance: Proficient with Oracle Argus Safety in Business configurations and Validation testing. Below are the key highlights of my expertise in Argus Safety: - Argus & Flexible Code Lists- Letter Configuration- Product, Licenses and Study configurations- Reporting destinations and Reporting Rules – E2B reporting, Paper (CIOMS/MedWatch) reporting- Access Management – configuration of users, user sites, user groups- Case Priority- Case Workflow and Workflow Rules configuration- Field label and validation configuration- Common Profile Switches- Auto narratives - DTD Message Profile From the perspective of business process and consulting, I come with below knowledge and experience: - Determining requirements and authoring Requirements Specifications document.- Validation Test Plan - outlining the validation SDLC, test strategy and test scenarios.- Authoring & review of IQ/OQ/PQ scripts for business configurations, system, user acceptance testing and Axway onboarding testing (with health authorities & business partners).- Discrepancy/Deviation Management and Issue resolution. - Authoring, review, and maintenance of the requirements-traceability matrix throughout the validation cycle of the project. - Authoring the validation and test summary report. As for my experience in PV for Pharmaceutical companies, highlights are listed below:- Case processing on Argus Safety and ArisG. - Team management and end-to-end client dealings with quality feedback, setting objectives and training of resources.- Duplicate detection of ICSRs in EMA database: Searching, identification and management of duplicates in EMA, along with de-duplication of ICSRs under one master case to reduce false signals. - Setting up workflow processes with data exchange and reconciliation, and providing inputs for modification of SOPs for efficient target meet.- Consistent exposure to marketed products and clinical trial development phases products with respect to their adverse event reports, product SPCs/investigator brochures and clinical trial CRFs.- Hands-on experience in regulatory submissions, ICH guidelines compliance requirements, and product related queries. - Actively involved in audits.