Vinay Rathod Email and Phone Number

Well-versed with ICH, Good Clinical Practice (GCP) & Ethical guidelines Clinical Trials, Clinical trial management, Phases 0, I, II, III, IV, Protocols, Reports, ICF, eCRF, Trial Master File/eTMF, CFR, INDA, NDA, ANDA, & BLA Data Management, Data Collection, CRF Tracking, Data Entry, Data Review, Data Validation, Discrepancy Management/Query Resolution, Medical Coding, & SAE Reconciliation, Data Audits, Database Lock Drug Safety, Pharmacovigilance, ICSR, MedDRA, COSTAT, ART, WHO UMC, Naranjo, Aggregate reports, DSUR, PSUR, PADER & PBRER Medical Writing, Regulatory & Scientific Writings, Manuscripts, Abstracts, Posters, Medico-marketing Writings & Regulatory Affairs, Dossiers, eCTD, DMF & Regulatory submissions, Regulatory compliance Good Written and Verbal Communication/Interpersonal Skills Good at using MS Office (Word, PPT & Excel) & EndNote software Diseases - Diabetes, Cancer, Asthma, COPD, Hypertension, Haemophilia, Depression, COVID 19, etc.. Research & Project Management Skills with Teamwork Flexible and Punctual to time lines.