Medical Review & Medical Triage - Tata Consultancy Services
(2019-09 - 2022-06)
Project: Grunenthal Pharmaceuticals
- Perform case assessment, medical review, follow-up identification and provide medical expertise throughout the Pharmacovigilance Drug Safety process.
- Quality check of cases to perform data completeness, accuracy and consistency.
- Correct Triage of ICSR's including Adverse Drug Reaction detection, labeling and seriousness assessment.
- Ensuring adequate ICSR quality to support signaling activities and periodic reporting.
- Support and mentor new team members to develop in case processing and related activities.
- Comply with applicable Grunenthal process, policies, SOP's and other procedural documents as applicable.
- Perform monthly Quality Control of ICSR'S with appropriate tracking as per assignment.
- Event coding, medical review, company causality assessments, checked detailed information of adverse events from reported source document, performed initial check and duplicate search.
Shift Lead - Tata Consultancy Services
(2018-10 - 2019-08)
Project: DowDuPont. Divestiture of DowDuPont by doing Spin of Company to create three independent Company namely DuPont De Numers, Corteva Agriculture and Dow Chemical Company. Controlled for stabilization before and after Go-Live of the three independent companies.
Focused on providing elevated level of support during Divestiture. During this process there was dedicated process, resources and tools available to resolve issues that may arise. In other word, it was the transition period in which various process and tools were brought together in the event of increased issues, when experienced post implementation.
The above activity was called Hypercare and consisted of different component of activities and entity.
- Command Center: It was a focal point for critical issues, used to prioritize and remove barriers, and I worked in this Command Center.
- Daily Defect Checkpoints: Triage and monitoring of issues, tracking resolution progress, reconciliation of issues.
- Application life cycle management tool (ALM): Centralized issue tracking tool used by the project teams to record work, resolve and report on issues.
- Business Process ? Work Stream Expert: to facilitate rapid application and function of issue resolution.
- Leadership Status / Reporting: Scheduled communication updates, summary of key operation metrics, imports, defects etc.
Medical Associate - Tata Consultancy Services
(2017-10 - 2018-02)
Project: GlaxoSmithKline Pharmaceutical
- Updating documents like Clinical Trial Monitoring Visit Report to Computer Assisted Research Study (MVR to CARS).
- Checking document while updating into CARS.
- Regional language documents getting it translated and updating in CARS.
Governance Associate - Tata Consultancy Services
(2017-04 - 2017-06)
Project: State Bank of India
- Report Level Merger and Data Merger of State Bank of India by doing merger of 5 Banks namely Bank of Hyderabad, Bank of Patiyala, Bank of Travancore, Bank of Punjab etc.
Drug Safety Associate - Tata Consultancy Services
(2014-09 - 2016-05)
Project: AstraZeneca
- Creation, review and dissemination of new / revised SOP's / OPI's to the target audience and tracking compliance to all applicable SOP's / OPI's, regulation, rules, laws and statutes with regard to GCP regulation in the Client domain.
- Responsible for maintaining Project documents.
- Participate in internal and external audits for the client operation.
- Responsible for implementing the inspection readiness as per the applicable procedurl documents.
- Single point of contact for the Quality Co-ordinator activities which includes maintaining personal files of all the associates training files and all the procedural documents.
- Ensure Compliance with respect to training requirement and documentation within the Project.
- Participate in training Programs.
- Provide need based support to Project Leader and Team Leader.
- Assist the Project Manager / Leader in setting up process meetings, generate MOMs (Minutes of Meeting).
- Responsible for planning and arranging L&D session for the team.
Junior Medical Data Analyst - Cognizant Technology Solutions
(2009-03 - 2013-07)
Project: Novartis Pharmaceuticals
- Processed Pharmacovigilance Drug Safety cases of Post-Marketing Surveillance, Spontaneous case and occasionally legal cases also.
- Handling of ICSR's which included initiation of case, data entry and sending acknowledgement and queries to the SAE responsible.
- Enter initial and follow-up information for individual adverse evens case reports onto the global Patient Safety Database, using data interpretation, coding and writing skills in accordance with the current Data Entry Process Instruction and associated SOP's and OPI's to ensure consistency of case entry and high data quality standards.
- Perform all activities within the required time frames to ensure regulatory compliance.
Resident Medical Officer - Sunflower Hospital
(2007-07 - 2008-09)
- Admitted patient under various consultants and took medical history and monitoring their recovery as per Hospital procedure.
- Perform all clinical procedure while performing Medical officer duties and assisted them in admitting patient under them and prescribing medicines as per the consultants guidelines and supervision.
