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Pallavi Babar

Clinical Data Management & Drug Safety | B.Pharm | CRC Experience | Medidata Rave, Oracle Clinical, MedDRA, ICH-GCP E6(R3) | Seeking CDM/Pharmacovigilance Roles at CROs

Pune City

1+ year of work experience

Pulse Multispeciality Hospital
Jan 20267 mosPresent

Pune, Maharashtra, India

Coordinate and support clinical trials in compliance with study protocols, ICH-GCP guidelines, and regulatory requirements • Assist in patient screening, recruitment, and informed consent process • Maintain accurate source documents, CRFs, and Investigator Site File (ISF) • Ensure proper documentation and timely data entry • Monitor and report Adverse Events (AEs) and Serious Adverse Events (SAEs) as per protocol • Support Ethics Committee submissions and regulatory documentation • Coordinate with investigators, sponsors, and study teams for smooth trial conduct • Ensure patient safety, data quality, and protocol adherence
Sahyadri Hospitals
Oct 20253 mosDec 2025

On-site

Sahyadri Hospitals
Oct 20253 mosDec 2025

Pune, Maharashtra, India

Education

Mitcon biotechnology and pharmaceutical centre

Bachelor of Pharmacy - BPharm, Pharmacy

Smt kashibai navale college of pharmacy

20214 yrs2025

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Headline

Clinical Data Management & Drug Safety | B.Pharm | CRC Experience | Medidata Rave, Oracle Clinical, MedDRA, ICH-GCP E6(R3) | Seeking CDM/Pharmacovigilance Roles at CROs

About

B.Pharm graduate with hands-on experience as a Clinical Research Coordinator and formal training in Clinical Data Management and Pharmacovigilance. Skilled in EDC systems (Medidata Rave, Oracle Clinical), CRF/ISF documentation, source data verification, and query resolution, with working knowledge of MedDRA coding, ICSR processing, and AE/SAE reporting under ICH-GCP E6(R3). Transitioning into Clinical Data Management / Safety Science Analyst roles at CROs, where I can apply my attention to detail, data quality mindset, and regulatory awareness to support clean, audit-ready clinical trial data. Open to: Clinical Data Associate | Clinical Data Management Trainee | Pharmacovigilance/Drug Safety Associate | Safety Science Analyst

Location

Pune City

Work experience

Clinical Research Coordinator at Pulse Multispeciality Hospital, Jan 2026 - Present · 7 mos, Pune, Maharashtra, India, Coordinate and support clinical trials in compliance with study protocols, ICH-GCP guidelines, and regulatory requirements • Assist in patient screening, recruitment, and informed consent process • Maintain accurate source documents, CRFs, and Investigator Site File (ISF) • Ensure proper documentation and timely data entry • Monitor and report Adverse Events (AEs) and Serious Adverse Events (SAEs) as per protocol • Support Ethics Committee submissions and regulatory documentation • Coordinate with investigators, sponsors, and study teams for smooth trial conduct • Ensure patient safety, data quality, and protocol adherence

Clinical Research Coordinator at Sahyadri Hospitals, Oct 2025 - Dec 2025 · 3 mos, On-site

Clinical Research Coordinator at Sahyadri Hospitals, Oct 2025 - Dec 2025 · 3 mos, Pune, Maharashtra, India

Education

Mitcon biotechnology and pharmaceutical centre

Bachelor of Pharmacy - BPharm, Pharmacy, Smt kashibai navale college of pharmacy

Pallavi Babar - Clinical Research Coordinator in Pune City | Tal