Motivated and detail-oriented Pharm D graduate with advanced certifications in Clinical Research, Clinical Data Management, Pharmacovigilance, and Regulatory Affairs. Possess internship experience in hospital-based clinical practice and strong foundational knowledge of ICH-GCP guidelines, CRF/eCRF, regulatory documentation, and pharmacological therapies. Eager to contribute to clinical research or data-driven roles in the healthcare industry.
I gained hands-on exposure to protocol review, ICH-GCP practices,Study designing, and regulatory documentation workflows. I also worked on eCRF designing, data collection and validation, UAT execution, discrepancy handling, and generating clean files—giving me a solid foundation in the end-to-end CDM process.
Clinical trial phases (0–IV), drug discovery & development
Protocols, CRF, eTMF, ICF, placebo, bias, study designs (RCTs, observational, cross-sectional, case-control)
ICH-GCP, CFR guidelines, roles of CRA/CRC/Sponsor/Investigator
CDM lifecycle: Study start-up (CRF design, database setup)
Conduct Phase (data collection, CRF tracking, data entry, data review, data validation, edit-check programs, UAT, discrepancy management, medical coding, SAE reconciliation)
close-out Phase (clean file, database lock)
Familiar with 21 CFR Part 11 and tools like Medidata Rave, Oracle Clinical, MACRO
AE, ADR, SAE, SUSAR handling, ICSR processing
Familiar with PV guidelines (ICH E2A–E2F, GVP, CIOMS), PVPI
Exposure to MedDRA and FDA coding standards
Regulatory pathways: INDA, NDA, ANDA, BLA, MAA
Regulatory submissions, DMF, eCTD (Modules 1–5), global regulatory bodies (FDA, EMA, CDSCO)
Therapeutic knowledge in Diabetes, Asthma, Hypertension, COPD, Cancer etc,
Advanced Certification Course in Clinical Research, Clinical Data Management, Pharmacovigilance, & Regulatory Affairs, CliniWings – Clinical Research Training Institute
Medidata Rave
Oracle clinical
MedDRA
Reading books Pharmacology, Farming, Travelling, Playing Cricket, Chess, Badminton.
Clinical Data Management
Clinical Research Associate
Pharmacovigilance
Regulatory Affairs
Medical Affairs
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