Praveen (Kumar) A.
Safety Regulatory Intelligence Consultant
Experience
Oct 2023 - Dec 2024
1 year 3 monthsGermany
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
- Tools used: SharePoint, JIRA, Miro
Sep 2022 - Mar 2024
1 year 7 monthsGermany
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; handover documents
- Tools used: SharePoint, HP ALM, JIRA, Microsoft tools
Jan 2022 - Jun 2024
2 years 6 monthsGermany
Business Analyst and SME
Merck KGaA
- Provide operational support and 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
May 2021 - Jun 2022
1 year 2 monthsGermany
Validation Manager
Merck KGaA
- Perform 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; closure and handover documents
- Tools used: HP ALM, SharePoint, ManGo (DMS), Microsoft tools
Aug 2020 - Dec 2020
5 monthsGermany
Business Architect
Merck KGaA
- Provide technical advice on the development of a software intelligence tool for monitoring worldwide legislation changes in pharmacovigilance and safety activities
- Application: Pharmacovigilance Intelligence Tracking System (PITS)
- Activities: Requirement gathering; preparation of URS; vendor selection; conceptualization of the system; defining workflow; closure and handover documents
- Tools used: ManGo (DMS), Miro, JIRA, Microsoft tools
Jan 2011 - Aug 2020
9 years 8 monthsSoftware Test Engineer, Test & Validation Lead
ArisGlobal Pvt Ltd.
- Perform software testing, validation, and implementation of pharmacovigilance and safety applications (ARISg)
- Application: Adverse Reaction Information System (ARISg), Electronic Submission Module (ESM)
- Activities: Requirement gathering; client meetings; preparation of URS, test plan, 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, Sahi automation tool, Microsoft tools
Feb 2009 - May 2010
1 year 4 monthsBusiness Process Executive
Infosys Pvt Ltd.
- Provide technical support and troubleshooting of telecom and internet services over calls to end users for the British Telecom Application (SMART)
Jul 2008 - Feb 2009
8 monthsComputer Science Lecturer
SDA & SA Pre-University College
- Teach computer science to pre-university students
Dec 2003 - Dec 2004
1 year 1 monthMedical Representative (FSO)
Glenmark Pharmaceuticals
- Meet medical professionals at clinics, hospitals, and nursing homes to promote new drugs and raise awareness of new therapies and treatments
Summary
Experienced Test / Validation and Implementation Lead with a demonstrated history of working in the computer software industry.
- User Requirements gathering
- Configuration
- Software Testing
- Computer System Validation
- Software Implementation
I have extensive experience of over 14 years in the Pharmacovigilance, Drug Safety and Regulatory applications within the pharmaceutical industry.
Languages
English
AdvancedGerman
IntermediateEducation
Visvesvaraya Technological University, SJCE Engineering College
Master in Computer Application · Computer Application · Mysuru, India
Certifications & licenses
Piano, Classical Guitar Practical And Music Theory Exams
Trinity College Of Music, London
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