Hemamalini Ravi
Chennai
Summary
Dedicated and focused project management specialist with several years of experience excelling at prioritising, completing multiple tasks simultaneously and following through to achieve project goals. Flexible, detail-oriented and adaptive team player with expertise in equipment operation, staff training and development, customer service and process improvements.
Having total of 15+ years of experience including onsite work experience of 1 year and 2 months and currently associated with HCL Technologies Ltd., Chennai. Have thorough understanding of Healthcare & Life Science domain with relevant experience of 14+ years and worked with Major Pharma clients - Pfizer, MSD and Organon. Expertise in providing functional and technical support and in developing custom solutions for widely used Oracle Argus Safety and Interchange applications. Having experience in leading and working in complex upgrade projects and extensive knowledge in developing and implementing customisations to E2B R2, E2B R3, eVAERS, eMDR, MIR and MedWatch profiles per Market/ Regulatory requirements. Good understanding of regulatory standards like 21 CFR Part11, ICH and GxP.
Overview
15
15
years of professional experience
Work History
Project Manager
HCLTech Ltd.,
Chennai
05.2023 - Current
- Led project planning and execution for two major upgrades completed for Client’s Oracle Argus Safety system.
- Coordinated cross-functional teams to ensure effective communication and collaboration.
- Managed project timelines, and resource allocation for successful outcomes.
- Responsible to manage client deliverables from offshore and leading a 15 member team.
- Accountable to work with Business on the requirements and to develop custom solutions for regulatory requirements.
Principal Business Analyst
RxLogix Co.,
Noida
05.2022 - 04.2023
- Accountable for handling delivery management and escalation from offshore.
- Responsible to lead major/minor releases for Business / Regulatory requirements.
- Responsible to provide status updates ton critical project deliverables to leadership team.
- Responsible to lead and guide team on the technical/functional support, process and validation activities to be followed for the client deliverables.
- Responsible to develop custom solutions for Business requirements.
Senior Technical Lead
HCL Technologies Ltd
Chennai
12.2019 - 04.2022
- Merck AMS Consolidation MRL supports major Safety applications. The major application, ARGUS is Merck’s global safety database and adverse event (AE) reporting system. Argus includes integrated workflow management and other automated functions to streamline the collection, analysis and reporting of safety data.
- Responsible to manage team size of 5 and handle escalations.
- Handled end-to-end activities to implement all the Business requirements for Brexit release.
- Have implemented technical solution for Business requirement to auto-generate narrative information with available case data information following chronological order.
- Accountable to handle major/minor releases for Business/ Regulatory requirements.
- Accountable to guide team on the change management process and validation activities to be followed for all the backend data and configuration changes to be implemented for Argus Safety and Interchange (E2B and eVAERS) and other applications in support scope.
- Have good experience in writing test scripts and doing test executions in ALM.
- Accountable to develop/modify monitoring queries for Business to perform compliance tracking.
- Responsible to handle L3 tickets involving technical/ functional expertise.
Technical Lead
Tejasco Techsoft Private Ltd.
09.2018 - 11.2019
- Merck AMS Consolidation MRL supports majorly Argus Safety and other PV applications used to record, analyze and report adverse events related to company products to Health Authorities/ Business partners operating globally.
- Operating from Client’s location and played a key role during hypercare support period post application upgrade to version 8.1.2. Have coordinated with Client and Project teams during implementation and planning of hypercare releases.
- Accountable to guide team on the change management process and validation activities to be followed for all the backend data and configuration changes to be implemented for Argus Safety and Interchange (E2B and eVAERS) and other applications in support scope.
- Responsible to handle major/minor change implementations for Argus application which includes upgrade, data and configuration changes for Business/ Regulatory requirements.
- Accountable for developing and implementing customizations to E2B, eVAERS and eMDR profiles per Health Authority/ Business Partner requirements.
- Responsible to develop PL/SQL scripts for backend changes and complex SQL queries for compliance monitoring.
Senior Consultant
HCL Technologies Ltd
07.2013 - 09.2018
- Merck AMS Consolidation MRL supports major Safety applications. The major application, ARGUS is Merck’s global safety database and adverse event (AE) reporting system. Argus includes integrated workflow management and other automated functions to streamline the collection, analysis and reporting of safety data.
- As a Team lead, responsible for managing deliverables related to Argus safety, ESM and Emperica tools.
- Responsible to implement all the backend data and configuration changes for Argus Safety and Interchange (E2B and eVAERS) module.
- Have considerable understanding on aggregate/ periodic reporting and have handled L3 tickets reporting data issues with periodic/ aggregate report outputs generated and submitted to Regulatory authorities from Argus Safety.
- Accountable to co-ordinate with Vendor for the service requests created to investigate on the root cause, corrective and preventive actions for the identified problem.
- As a Team member, responsible to investigate on the non-routine issues being reported and to review the System and Business Configuration changes being implemented for Argus Safety.
- Having good knowledge on Argus Safety Database.
- Working Extensively on Quest software – TOAD and responsible to develop PL/SQL scripts for backend fixes identified.
- Responsible for Configuration changes on ESM Mapping tool.
- Have performed in MedDRA and Rightfax upgrades.
- Accountable to train new resources on the application and support processes.
- HCL Certified trainer to deliver training sessions on Argus Safety Implementation essentials (Internal).
- Have hands on with eVAERS (R3) configuration and support.
Support Analyst
Pfizer
03.2011 - 05.2013
- Medical BT – WSS&O supports major Safety applications. The major application, ARGUS is Pfizer’s global safety database and adverse event (AE) reporting system. Argus includes integrated workflow management and other automated functions to streamline the collection, analysis and reporting of safety data.
- Responsible for handling Production tickets, analyzing issues and providing resolutions.
- Regular monitoring of alerts on all production servers.
- Daily and Monthly Report Generation.
- Tracking Knowledge base utilization and creating / modifying KBAs as required.
- Responsible for providing KT sessions for new joiners.
- Have been a part of the Process Improvement team for all Pfizer-WRD Engagements.
Software Engineer
Pfizer
09.2010 - 12.2010
- Pfizer Manufacturing BT planned to consolidate its current support model for Plant level systems. As a result, Pfizer is looking to gain visibility into Plant Level Systems and build detailed documentation with a focus on using this documentation for transitioning support into new support model. The templates were leveraged to build Pfizer plant systems documentation. The documents were handed over to Pfizer in word format.
- Preparation of Pfizer plant system documents.
- Review of Pfizer plant system documents.
Education
B.E - Electronics & Communication Engineering
R.M.D Engineering college
KavaraipettaiSkills
- Oracle Argus Safety - 8442, 8402
- Oracle PL/SQL
- JIRA
- ServiceNow
- SQL Developer
- ALM
Accomplishments
- Obtained Argus Safety 7 Implementation Specialist certification.
- Received O2 award for the outstanding performance noted in consecutive review periods.
- Awarded 'LIVE WIRE' and SPOT awards for distinguished performance in critical projects.
Languages
English
First Language
Tamil
Proficient
C2
Timeline
Project Manager
HCLTech Ltd.,
05.2023 - Current
Principal Business Analyst
RxLogix Co.,
05.2022 - 04.2023
Senior Technical Lead
HCL Technologies Ltd
12.2019 - 04.2022
Technical Lead
Tejasco Techsoft Private Ltd.
09.2018 - 11.2019
Senior Consultant
HCL Technologies Ltd
07.2013 - 09.2018
Support Analyst
Pfizer
03.2011 - 05.2013
Software Engineer
Pfizer
09.2010 - 12.2010
B.E - Electronics & Communication Engineering
R.M.D Engineering college