Manigandan Devan
Safety Database Consultant
Darmstadt
Summary
An enthusiastic & proactive software professional with 12+ years of experience in the field of Drug Safety Application & Database Management, Validation & Consulting. Extensive experience with Safety database applications like LSMV, ARGUS, ARGUS Interchange, Arisg, agXchange, Safety Test, PV Reports, ESM & BizConnect. Experience in leading project, played key role in a major safety database upgrade project(LSMV).
Overview
10
10
years of professional experience
1
1
Certification
Work History
Consultant
JSC Management- und Technologieberatung AG
06.2021
- Played a key role as Workstream lead in a 2.5 years platform upgrade project
- Took the responsibility of Case Data, Administration migration mapping documents and completed successfully
- Played a role of project manager, maintaining the ticketing system(JIRA), providing project status using dashboards, Leading On-site Testing sessions
- Validating migration from Perceive Safety Database to LSMV
- Additionally supported as a Regional workstream lead to China, Korea and Japan and resolving all the issues during the project phase
- Involved in Audit Preparation like User accounts preparation, Business Operation Manuals update
- Expertise with the LSMV database model and provided listing like Vendor Turn Around Time listing & Intake KPI listing.
Senior Consultant
ARIS Global GmbH
08.2018 - 06.2021
- As a change management manager leading a team in implementing all the control with Change Control Process in Merck Healthcare KGaA
- Maintenance of MedDRA upgrade twice in a calendar year as a standard change control
- Maintenance of periodic activities like Auto Labeling
- E2B export/import project, complete business testing
- Recent set up was Australian Health Authority (TGA) went live in August 2019
- Support to the application (Safety Test) with daily activities and in change control activities
- Responsible for all the validation documents (Functional Specification, Change Request, Deployment Plan, OQ, OQ Report, Deployment Report)
- Single point of contact for all ARIS J service requests
- Responsible in requirements gathering for all the change control topics, planning and validating all the implemented changes.
Senior Business Analyst
RxLogix, Japan
11.2017 - 07.2018
- Requirements gathering for In-house product (PV Reports) to start with Japan Reporting features (JPSUR, JDSUR, NUPR and other line listing reports for clinical agencies)
- Played a major role in requirement gathering, validation testing and in report deliverables
- Conducted consortium with MSD Japan, Novartis and Alexion Pharma to identify and gather the current pain points in Japanese reporting to implement in PV Reports Japan.
Senior Network Engineer
Tech Mahindra, Japan
07.2016 - 11.2017
- Validation testing at client location Kyowa Pharmaceuticals
- Creating UAT scripts for Bristol Myers Squibb
- Onsite Argus Support for Bristol Myers Squibb
- Oracle Argus upgrade from 6.0.7.7 to 8.1 for Hitachi Limited
- Supported in Data Migration project.
Technical Analyst
Oracle, India
07.2014 - 07.2016
- Supporting leading Pharma companies like Pfizer, Novartis, Novo Nordisk, Baxter etc
- In a time span of 7 months resolved 150+ Service Request which includes several Backlogs
- Argus Safety Installation/Upgrading
- Argus Safety Configuration
- Identifying failures/error messages
- Argus Module Configuration
- Identifying Argus Error messages and Trouble Shooting
- Argus Safety Case Management.
IT Analyst
Synowledge PV Services
06.2012 - 07.2014
- Providing Superior Support in ARISg Application and Troubleshooting ARISg related issues and providing workarounds
- Maintaining ARISg administration and involved in administrator activities like User maintenance, Roles & privileges, Parameter maintenance, Adding/updating/deleting company products, Bookmark maintenance, Creation of company units and setting up distribution rules, Maintaining Codelist, Developing Custom validations & Custom Workflow
- Developing reports as per the business requirement by querying the database and providing the reports as expected
- Also involved in writing large & complex queries for projects like Signal Detection & Reconciliation reports
- Developing PLSQL subprograms to support the custom validations, Routing case from a workflow activity, Workflow due date calculation etc
- Involved in developing the Validation package (URS, FS, DS, IQ, PQ and OQ)
- Participating in functional trainings conducted internally (Synowledge PV Services) and gathering knowledge in Pharmacovigilance, Drug Safety, Submissions etc
- Setting up Regular meetings with the business users and prioritizing tickets and resolving issues based on the timelines.
Technical Analyst
Intellectual Safety Net, India
05.2011 - 06.2012
- ARISg & agXchange Application support and maintenance
- Data extraction and development of ad-hoc reports
- Database migration from Oracle 10.2.0.3 Enterprise Edition to Oracle 10.2.0.3 Standard Edition
- Loading MedDRA & WHODD as and when required
- Involved in developing custom workflows, rules, custom validations and reports as per the requirements
- Database maintenance
- Adding space to data files, responsible for database start up and shutdown activities.
Education
Masters in Software Systems -
Bharathiyar University
Skills
Drug Safety Systems
undefinedAccomplishments
- Won Phoenix Award from Merck Healthcare KGaA
- ITIL Foundation Certified
- PRINCE2 Agile Foundation Certified
- Deutsch-Test für Zuwanderer – B1
- JLPT (Japanese Language Proficiency Test) – N3 Certified
- Won 2013 LEADERSHIP AWARD for “THE BEST PERFORMER – IT” – Synowledge
- Received Cash Reward in Oracle for Best Feedback from Shionogi Pharma, Japan
Areas Of Interest
- Drug Safety Systems (LSMV, Veeva & ARGUS)
- Pharmacovigilance
- SQL & PL/SQL
- Project Management
- E2B Submissions
- Validation
- Business Objects
- Crystal Reports
- Signal Detection & Risk Management
Personal Information
- Nationality: Indian
- Visa Status: Niederlassungserlaubnis
Certification
ITIL
Timeline
ITIL
03-2023
Consultant
JSC Management- und Technologieberatung AG
06.2021
Senior Consultant
ARIS Global GmbH
08.2018 - 06.2021
Senior Business Analyst
RxLogix, Japan
11.2017 - 07.2018
Senior Network Engineer
Tech Mahindra, Japan
07.2016 - 11.2017
Technical Analyst
Oracle, India
07.2014 - 07.2016
IT Analyst
Synowledge PV Services
06.2012 - 07.2014
Technical Analyst
Intellectual Safety Net, India
05.2011 - 06.2012
Masters in Software Systems -
Bharathiyar University
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