Manigandan Devan Email & Phone Number

Darmstadt, He, De

Eltville, Hesse, Germany

• I played a significant role as the Workstream lead in a safety database upgrade project that lasted for 2.5 years• Managed various aspects including reviewing migration mapping documents, gathering requirements, updating configuration specifications, managing rapid implementation templates, planning tests, verifying submissions and validating each release thoroughly• Acted as a project manager, overseeing the ticketing system (JIRA), delivering project updates through dashboards, and leading on-site testing sessions• Validating the migration process from the Perceive Safety Database to LSMV• Furthermore, provided support as a regional workstream lead for China, Korea, and Japan, addressing all project-related issues during the phase• Engaged in audit preparation tasks such as preparing user accounts listing and updating business operation manuals• Proficient in the LSMV database model and generated listings such as Vendor Turn Around Time and Intake KPI

Darmstadt Area, Germany

• 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. • 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.• In addition to the above roles, also responsible to support the daily maintenance activities team members as and when required.

Within 23 Wards, Tokyo, Japan

• 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.

Within 23 Wards, Tokyo, Japan

• Validation consultant for Kyowa Pharmaceuticals for Argus Safety upgrade.• 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.

Bengaluru Area, India

ROLES AND RESPONSIBILITIES: • Supporting leading Pharma companies like Pfizer, Novartis, Novo Nordisk, Baxter, Astellas, Daiichi Sankyo etc.• Argus Safety Installation• Argus Safety Business Configurationo Product and Licenseso Studies Configurationo Configuration of Reporting Ruleso Configuration of Reporting Destinations Inbound/outbound E2B Adding Partners• E2B/Email/Print• Advanced Condition o Using Advanced Conditions during configuration• Argus Safety System Configurationo Access Managemento Workflow Use of dynamic workflowso Code listo Field Labels/UD fieldso Field Validationso System Numberingo Prioritieso Common Profile Switcheso AG-Services• Identifying failures/error messages• Interchange Profileso Flow of data • Argus Module Configurationo Argus Local Affiliateo Argus Safety Japano Argus Un-blinding• Identifying Argus Error messages and Trouble Shooting• Argus Safety Case Management

Bangalore

ROLES AND RESPONSIBILITIES: • 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. Also involved in gathering the USER REQUIREMENTS by directly interacting with the business users.• 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).• Loading and recoding MedDRA twice in a calendar year and Loading WHODD as and when required by the business users.• Mentoring junior colleagues and provided KT based on my experience.• Developing Reports using reporting tools like Business objects & Crystal Reports.• 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.

Hyderabad Area, India

ROLES AND RESPONSIBILITIES: • 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.• Responsible for Database Maintenance.

Master'S Degree, Software Systems

Education record

Education record