Govindarao M Email & Phone Number

 Familiar with Pharmacovigilance (drug safety) business processes for case processing and reporting, safety solutions, PV safety databases and Computer System Validation (CSV) procedures. Hands-on with business and system configuration of safety solution. Experience in working directly with customers conducting through workshops.  Familiar with configuration and maintenance of product and license information, reporting rules, clinical studies and user information within PV Safety databases.  Experience in implementation and support of PV safety systems- E2B import and E2B (R2/R3) XML export of electronic files from Regulatory Agencies, license partners via a Gateway. Collaborate externally and attend relevant industry conferences and information days to maintain knowledge and understanding of best industry practices for managing safety systems. Performing PQ testing and validation during system upgrades and migrations. Support Inspection and Audits. Initiation of change requests (CR) through change control queue for new or customized configuration requests and ad-hoc requests. Basic knowledge about ICH-GCP guidelines, 21CFR Part 11, EU Annexure 11, GAMP5, SQL/PSQL.  Experience in development of system support related process, SOPs, Work Instructions and user guidance manuals. Responsible for handling of data processing concerns, validations, study configurations, reporting rules, labeling, MedDRA coding, Labeling, submission related issues -negative ACKs, user licenses, SOP, WI, user guidance documents, end-user training, knowledge transfer, CAPA. In-depth knowledge on ICSR end-to-end process (intake, triage, data processing, coding, quality review, submission), handled all type of cases -literature (abstract review, literature ordering, MLM), legal, clinical study, Study configuration, Library management, company product configuration, reconciliation.  ICSR submission/Reporting rules: Gathering requirements from HA, LSO, Partners, preparation of UAT scripts, testing, implementation, GAP analysis, KPI monitoring, reporting rules matrix review, implementation of validation rules and reporting rules, handling of rejections/negative acknowledgments from Regulatory authorities and partners. Collaboration with licensing partners, local safety offices, QPPV, Health Authorities regarding reporting rules implementation and automated process of PV safety databases.  Working experience with various leading companies like Quintiles (IQVIA), Bioclinica, Aris Global, Veeva vault, Prudentia, Teva.