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Ritu Sharma

Clinical Data Coordinator | Pharmacovigilance | Medical Record Abstraction | GMP/GCP Compliance | Open to Remote Opportunities

Bengaluru

3+ years of work experience

Omega Healthcare Management Services
Aug 20251 yr 2 mosPresent

Bengaluru

Clinical Data Abstraction & Validation: Conduct high-volume, highly accurate abstraction of critical data points from EHRs and patient charts (e.g., diagnoses, procedures, treatment plans). Ensure strict adherence to project SOPs and healthcare regulations (HIPAA), maintaining 98%+ data quality for downstream analytics. • Abstracted 50+ records/day from EHRs at 98%+ accuracy • Applied HIPAA, ICH-ICSR standards to all case documentation • Worked independently in a remote-compatible, deadline-driven environment
Feb 20257 mosAug 2025

Bengaluru, Karnataka, India

Understanding of clinical trial phases and documentation. Knowledge of ICH-GCP guidelines
SUN PHARMA
Nov 20231 yrOct 2024

Vadodara, Gujarat, India

Hands-on expertise in the production of Sterile dosage form ‘AMPHOTERICIN’ in a cGMP-compliant environment. ● Orchestrating change control through QMS and qualification Protocols. ● Perform risk assessments, SOP’s Preparation and oversee discrepancies, deviations and CAPA. ● Ensuring Compliance with GMP/cGMP standards and addressing QA observations . ● Managing audits from USFDA, WHO and CDSCO.
Sun Pharmaceutical Industries Ltd.
Nov 20231 yrOct 2024

Authored and executed IQ, OQ, PQ qualification protocols, URS, FS, DS, and SOPs for automated manufacturing systems on the Greenfield Amphotericin project. Led challenge testing scenarios to validate system alarms, automated controls, and operational parameters prior to system release. Managed system non-conformances, Deviations, and CAPAs using TrackWise; controlled GxP documentation in Documentum D2 EDMS. Supported compliance readiness and audit trail reviews during USFDA, WHO, and CDSCO regulatory inspections.
Cipla
Feb 20239 mosOct 2023

Indore, Madhya Pradesh, India

Hands-on expertise in the production of Sterile dosage form in a cGMP-compliant environment. ● Engaged in Quality Control Operations. ● Proficient in managing audits from USFDA, WHO, CDSCO and Russian Authorities. ● Demonstrates extensive expertise in regulatory complience.

Ritu’s AI Stack

claude
claude
gemini
gemini
perplexity
perplexity

Education

I. K. Gujral Punjab Technical University (IKGPTU)

Bachelor in pharmacy, Pharmacy

I. K. Gujral Punjab Technical University (IKGPTU)

20184 yrs2022

Bachelor of Pharmacy, Pharmacy

Swami Vivekanand College of Pharmacy

20184 yrs2022

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Headline

Clinical Data Coordinator | Pharmacovigilance | Medical Record Abstraction | GMP/GCP Compliance | Open to Remote Opportunities

About

B.Pharm graduate with 2+ years in pharmaceutical quality (Sun Pharma, Cipla) and hands-on experience in clinical data abstraction, medical record review, and GMP/cGMP compliance. Currently abstracting EMR data at 98%+ accuracy at Omega Healthcare. Formally trained in Clinical Research, Pharmacovigilance, ICSR processing, MedDRA coding, ICH-GCP, and Clinical Data Management (Advanced Diploma, CLRI 2025). Also certified in Clinical SAS and R Programming. ✔ Open to remote / work-from-home roles in CDM, PV, or Clinical SAS ✔ Available for full-time, part-time, or contract opportunities 📩 Let's connect: ritusharma0525@gmail.com

Location

Bengaluru

AI stack

claude

gemini

perplexity

Work experience

Medical Record Reviewer at Omega Healthcare Management Services, Aug 2025 - Present · 1 yr 2 mos, Bengaluru, Clinical Data Abstraction & Validation: Conduct high-volume, highly accurate abstraction of critical data points from EHRs and patient charts (e.g., diagnoses, procedures, treatment plans). Ensure strict adherence to project SOPs and healthcare regulations (HIPAA), maintaining 98%+ data quality for downstream analytics. • Abstracted 50+ records/day from EHRs at 98%+ accuracy • Applied HIPAA, ICH-ICSR standards to all case documentation • Worked independently in a remote-compatible, deadline-driven environment

Intern at Intern at Clinilaunch research Institute, Feb 2025 - Aug 2025 · 7 mos, Bengaluru, Karnataka, India, Understanding of clinical trial phases and documentation. Knowledge of ICH-GCP guidelines

Officer at SUN PHARMA, Nov 2023 - Oct 2024 · 1 yr, Vadodara, Gujarat, India, Hands-on expertise in the production of Sterile dosage form ‘AMPHOTERICIN’ in a cGMP-compliant environment. ● Orchestrating change control through QMS and qualification Protocols. ● Perform risk assessments, SOP’s Preparation and oversee discrepancies, deviations and CAPA. ● Ensuring Compliance with GMP/cGMP standards and addressing QA observations . ● Managing audits from USFDA, WHO and CDSCO.

Production Officer at Sun Pharmaceutical Industries Ltd., Nov 2023 - Oct 2024 · 1 yr, Authored and executed IQ, OQ, PQ qualification protocols, URS, FS, DS, and SOPs for automated manufacturing systems on the Greenfield Amphotericin project. Led challenge testing scenarios to validate system alarms, automated controls, and operational parameters prior to system release. Managed system non-conformances, Deviations, and CAPAs using TrackWise; controlled GxP documentation in Documentum D2 EDMS. Supported compliance readiness and audit trail reviews during USFDA, WHO, and CDSCO regulatory inspections.

Trainee at Cipla, Feb 2023 - Oct 2023 · 9 mos, Indore, Madhya Pradesh, India, Hands-on expertise in the production of Sterile dosage form in a cGMP-compliant environment. ● Engaged in Quality Control Operations. ● Proficient in managing audits from USFDA, WHO, CDSCO and Russian Authorities. ● Demonstrates extensive expertise in regulatory complience.

Education

Bachelor in pharmacy, Pharmacy, I. K. Gujral Punjab Technical University (IKGPTU)

Bachelor of Pharmacy, Pharmacy, Swami Vivekanand College of Pharmacy