ROHITH KUMAR
Drug Safety Associate
Hyderabad,Yes
Summary
To grow with a leading organization that utilizes my abilities to its possible extremities, helping me and develop my potential and be a part of the team that scales great heights through continuous learning process and utmost dedication.
Overview
3
3
years of professional experience
6
6
years of post-secondary education
2
2
Languages
Work History
Senior Process Associate
Tata Consultancy Services
Nagpur
04.2021 - 01.2024
- Ensuring completion of basic Pharmacovigilance training in case handling.
- Responsible for processing of different types of cases like spontaneous, Solicited and Partner Cases.
- Conducted thorough triage of incoming reports, validating completeness, duplicate checks, legibility, and ensuring data accuracy and compliance with regulatory standards.
- Utilized MedDRA, Company Product Dictionary, and WHO-DD for precise coding of medical history, adverse events, drugs/procedures, indications, and laboratory tests.
- Wrote medically relevant safety narratives, ensuring that al data fields were accurately completed, while maintaining high standards of clinical and regulatory compliance.
- Assessed expectedness, causality, and seriousness criteria for reported adverse events, ensuring accurate classification and adherence to pharmacovigilance guidelines
- Managed follow-up requests in a timely manner to gather additional safety information, ensuring the completeness of case files.
- Maintained process-specific trackers to manage workflow, ensuring efficient tracking and timely processing of adverse event reports.
- Performing Quality Checks before closure of cases.
- Identified and escalated literature and medical device safety cases to appropriate teams for further review and action.
- Participated in internal training sessions and project-specific workshops, continuously enhancing knowledge of pharmacovigilance processes and regulations.
- Completed all training assignments on the internal Learning Management System (LMS), meeting deadlines and ensuring proficiency in pharmacovigilance practices.
- Conducted quality reviews of cases, ensuring data integrity and compliance with pharmacovigilance standards.
- Led team operations and ensured the continuity of activities in the absence of the team leader, taking on leadership responsibilities to maintain smooth team functioning.
Education
Master of Pharmacy - Pharmaceutics
Annamacharya College Of Pharmacy
Razampeta, Andhra Pradesh 09.2017 - 09.2020
Bachelor of Pharmacy -
Santhiram College of Pharmacy
Nandyal, Andhra Pradesh 09.2014 - 04.2017
Skills
- Safety databases: Sapphire and Aris G
- Proficient in MedDRA and WHODD Standards
- Data Capturing, Case processing, Narrative writing in Pharmacovigilance
- Data analysis tools: MS Excel
- Good interpersonal skills
- Expertise in correlating patient medical history, laboratory data
- Appropriateness in selection of drugs
- Ability to manage time effectively and work independently
Areas Of Interest
- Pharmacovigilance
- Clinical Data Management
- Regulatory Affairs
Accomplishments
- Received Star of the month award in TCS.
Disclaimer
I hereby declare that the above particulars are true to the best of my knowledge and belief. If I am offered an opportunity to work, I will discharge the duties entrusted to me to the best of my capacity and to the entire satisfaction of my superiors.
Timeline
Senior Process Associate
Tata Consultancy Services
04.2021 - 01.2024
Master of Pharmacy - Pharmaceutics
Annamacharya College Of Pharmacy
09.2017 - 09.2020
Bachelor of Pharmacy -
Santhiram College of Pharmacy
09.2014 - 04.2017
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