Vimal Kumar
Senior Safety Consultant @Arcondis Group
Signup · Get unlimited contacts
WORK HISTORY
Senior Safety Consultant @Arcondis Group
Frankfurt, DE
EDUCATION
Sri Krishna Adithya College of Arts and Science
Master's degree, Computer Science
S N R Sons College
Bachelor of computer Applications, Computer Applications
ABOUT VIMAL KUMAR
12 years of IT consulting experience in Pharmacovigilance & Safety and Validation.• Safety Solutions (Validation & Configuration): Oracle Argus Safety Suite (v8.0 to 8.2), PV Intake, HLIT, Argus Console, Veeva Safety, PLSR and Advanced Conditions.• Computer System Validation (CSV): Project related Risk Assessment, Requirements Analysis, Validation deliverables for GXP and Non GXP in accordance with SOP• Safety Specialties- ICSR case processing, QR of ICSR, Expediting E2b reports(eVAERS, eMDR) to different HA - Submission to HA worldwide, monitoring Electronic Submission (ESM) status- Monitoring of CIOMS and E2B reports- Handling various regulatory requests from different stakeholders- Configuration and administration of User/User Group and Codelist- Configuration of Agency/Reporter/Studies/Products/Licenses - Configuration of License Partner, Configuration of Expediting rule. Configuration of Workflow- Extensive Knowledges on Safety Databases and Schemas of Argus Safety- Database Structure.• Regulations: FDA 21 CFR Part 11, EU cGMP Annex 11, Brexit Changes, Regulatory Requirements, Impact Assessment, Pharmaceutical Manufacturing.• Veeva Safety knowledge- Users, Reports & Dashboard Creations, Document Managements and Lifecycle, Workflows, Objects, Delegate Access, Document Delete- Dynamic Access Control, Object Workflow, Document Lifecycle, Configuration Migration, Loader (Import & Extraction)- Vault Loader & FTP Client, Mobile Set up, Emails & Notifications.• Vault: Vault Safety, PromoMATS. • Guidelines: GVP, GMP, GDP, FDA 21 CFR Part 11,CAPA Management, V Model, Agile, Electronic Document Management System (EDMS), E2B Submissions.• Testing: System testing, Integration Testing, GUI Testing, Exploratory testing, Black box techniques, Regression Testing, User Acceptance testing, Smoke testing, and RBT (Risk Based testing),RTM.• Tools: HPALM, JIRA, IBM Cognos, JReport, Spotfire, MS Office, SQL, Service Now.• Past PV Association Projects: GSK-Haleon, G1 Therapeutics, Merck, Otsuka, Parexel, Novartis.• Certification : Veeva White Belt Certification.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.