Praveen (Kumar) Kumar A
Safety Regulatory Intelligence Consultant
Experience
Safety Regulatory Intelligence Consultant
Sanofi Aventis Deutschland GmbH
- Provide expert advice and support in the development of a software intelligence tool for monitoring worldwide legislation changes in the field of post marketing safety and regulatory activities and implementation of process workflow
- Application: Safety Regulatory Intelligence
- Activities: Requirement gathering, conceptualization of process and workflow, vendor selection, etc.
- Tools used: SharePoint, JIRA, Miro
Sr. Validation Consultant
BioNTech
- Perform validation for the implementation of the new RIMS system at BioNTech and provide migration support and related validation activities from the old system to the new RIMS
- Application: Regulatory Information Management System (BRIMS)
- Activities: Requirement gathering, preparation of URS, validation plan, validation documents – IQ, OQ and PQ, support business users during validation, migration plan, migration test cases, validation and migration summary report and handover documents
- Tools used: SharePoint, HP ALM, JIRA, Microsoft tools, etc.
Business Analyst and SME
Merck KGaA
- Provide operational support, preparation of GxP and non-GxP releases per year and documentation for Patient Support Program application
- Perform audit trail review of GxP business requirements per year
- Update user and training manuals for end users and ensure completion per release
- Application: Patient Safety Program (PSP)
- Activities: Requirement gathering, preparation of URS, validation plan, validation documents – IQ, OQ and PQ, support business users during validation, conduct audit trail review of GxP requirements and documentation, ensure compliance by maintaining validated state of the application
- Tools used: HP ALM, SharePoint, ManGo (DMS), Veeva QMS, Microsoft tools, etc.
Validation Manager
Merck KGaA
- GxP validation of the new implementation of a complaint harmonization software tool
- Application: Complaint Management Tool (Broker)
- Activities: Requirement gathering, preparation of URS, validation plan, validation documents – IQ, OQ and PQ, perform validation activities and closure and handover documents
- Tools used: HP ALM, SharePoint, ManGo (DMS), Microsoft tools, etc.
Business Architect
Merck KGaA
- Provide technical advice on the development of a software intelligence tool for monitoring worldwide legislation changes in the area of pharmacovigilance and safety activities
- Application: Pharmacovigilance Intelligence Tracking System (PITS)
- Activities: Requirement gathering, preparation of URS, vendor selection, conceptualization of the system, defining of workflow, closure and handover documents
- Tools used: ManGo (DMS), Miro, JIRA, Microsoft tools, etc.
Software Test Engineer, Test & Validation Lead
ArisGlobal Pvt Ltd.
- Software testing, validation, implementation of pharmacovigilance and safety applications (ARISg)
- Application: Adverse Reaction Information System (ARISg), Electronic Submission Module (ESM), etc.
- Activities: Requirement gathering, client meetings, preparation of URS, test plan and test documents, validation plan, validation documents – IQ, OQ and PQ, perform validation activities, implementation and installation of software tools at client/AWS, support client validation activities
- Tools used: HP ALM, document management system, JIRA, SQL Developer, automation tool (Sahi), Microsoft tools, etc.
Business Process Executive
Infosys Pvt Ltd.
- Provide technical support and troubleshooting of telecom and internet services over calls to the end users of the client
- Application: British Telecom Application (SMART)
Computer Science Lecturer
SDA & SA Pre-University College
- Teaching faculty for pre-university students
Medical Representative (FSO)
Glenmark Pharmaceuticals
- Meet with medical professionals at clinics, hospitals, and nursing homes to promote new drugs and bring awareness of new therapies and treatments
Industries Experience
See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.
Experienced in Pharmaceutical (14.5 years), Biotechnology (1.5 years), Telecommunication (1.5 years), and Education (0.5 years).
Business Areas Experience
The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.
Experienced in Information Technology (13.5 years), Quality Assurance (12.5 years), Customer Service (1.5 years), Business Intelligence (1 year), Sales (1 year), and Procurement (0.5 years).
Summary
Experienced Test / Validation and Implementation Lead with a demonstrated history of working in the computer software industry. Skilled in – User Requirements gathering, Configuration, Software Testing, Computer System Validation and Software Implementation. I have extensive experience of over 14years in the Pharmacovigilance, Drug Safety and Regulatory applications within the pharmaceutical industry.
Skills
Software Unit Testing, Software Configuration, Integration Testing, Uat And Software Implementation.
Gxp Computerized System Validation/sdlc Activities Using Computer System Validation Regulations, Methods (E.g., Corporate Procedures, Code Of Federal Regulations (Cfr), Particularly 21 Cfr Part 11) And Data Integrity.
User Requirements Gathering, Analyzing, Recommendation Of Solution, Verification And Implementation.
Audit Trail Review Of Gxp Systems To Ensure Patient Safety, Data Integrity And Product Quality.
Domain: Pharmacovigilance, Drug Safety And Regulatory
Team Management: Have Been Privileged In Working Together In A Highly Skilled Environments, In Collaborating With Diverse Teams, And Actively Coordinating With Cross-functional Teams To Achieve A Common Goal Of Delivering Quality Software Solutions To Clients.
Leadership Skills: Over The Years In My Various Roles And Experiences, I Have Been Able To Learn And Lead Teams Successfully In Multi-cultural Environments To Clients From Different Regions With Clear Communication, Using Proper Problem-solving Techniques, Time Management And Decision Making.
Have Hands-on Experience In Software Testing, Computer System Validation, Customer Service/technical Support, Product Sales And Teaching.
Interpersonal Skills: Possess Strong Interpersonal Skills, Enabling Them To Diffuse Stressful Situations By Maintaining A Positive Atmosphere And Fostering A Collaborative Environment.
Emotional Intelligence: Demonstrated Emotional Intelligence, Adept At Calming Individuals In High-pressure Scenarios And Promoting Constructive Dialogue.
Communication: Proficient In Using Clear And Empathetic Communication To Soothe Concerns And Facilitate Understanding Among Team Members.
Honest, Optimist, Organized And Responsible
Good Analytical And Problem-solving Skills
Good Listener And Eye For Detail
Good Negotiation Skills With The Clients
Team Player And Individual Achiever
Excellent Written And Verbal English Communication Skills
Have Wide Experience In Various Fields With Different Roles And Responsibilities
Languages
Education
Visvesvaraya Technological University, SJCE Engineering College
Master of Computer Applications · Computer Application · Mysuru, India
Certifications & licenses
Classical Guitar Practical Exam
Trinity College Of Music, London
Music Theory Exam
Trinity College Of Music, London
Piano Exam
Trinity College Of Music, London
Profile
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