DRxAmit Modi — CEO

As Experienced Quality Clinical Research Pharmacologist with a demonstrated history of working in the Healthcare Sectors.Skilled in Clinical Trial Management System (CTMS),Pharmacy, Pharmacology,Physiology,Anatomy,Genetics PCR,Biotechnology,Cardiology,Neurology,Gastroenterology Pulmonology,Skeleton,Ophthalmology Embryology,Anesthesiology,Histopathology,Molecular Biology,Microbiology,Pharmaceutics,Emergency Medicine,ENT,Pharmacognosy,Pharmacovigilance,Clinical Research,Business Management,and Business Development.Strong research professional with a Masters Program focused on Dissertation or Thesis.I have developed my Expertise on BA/BE to CRO,Recombinant DNA Technology,Regulatory Protein’s,ADR Surveillance/AE,Clinical Trials Design,Data Management/Statistics,Protocol Preparation,Evaluation of Reports and Reports Writing,Risk Management Strategies,WHODD,CCDS,CCSI,Randomisation,IRB/IEC,GLP,GCL,CRF,eCRF,eCDM. Dr.C.V.Raman University (C.G)Kota,Bilaspur @ Have developed my Expertise meticulously on International Guidelines for Clinical Research,Systematic Review of Medical Literature and Medical Literature Analysis,Medical Research Writing,Advanced Research Bioinformatics,Ethics including Consent and Insurance,MedDRA,AE,SAE Reconciliation,Clinical Data Analysis,Clinical Data Management,Working Guidelines,ICH-GCP,CDSCO,MedDRA,Eudravigilance,USFDA FAERS,VAERS,CDER,CBER,Codes of Therapeutic Equivalency,Government Regulation. @ Have gained,Acquired Skills and Access the Information,Knowledge about USA 21 CFR Part 11,DMF,Global Submission of NDA,IND,And ANDA,IMPD,IB,CTD/eCTD,eTMF,US FDA,WHO,CIOMS,ICMR,Quality Audits and Inspections,CGMP/GLP,ISO 9000 Series,CMC. @ Have gathered Expertise on Regulatory Requirements of EU,MHRA,TGA,HC,ANMAT,PDMA,JPEC,MFDS,TFDA,NAFDC,DDA,NAFFAC,SAHPRA,ISPCH,MMDSA,ARCSA and ROW Countries,ICD,Pharmacovigilance Safety monitoring in Clinical Trials,MHA,PBRER,PADER,ICSR,SUSAR,PSURs,EMA,SmPC,PIL,Aggregate reports,Signal detection & Risk Management Plan,Drug Development Processes,Regulatory Affairs,Essentials Documentation,Roles and Responsibilities of Key Stakeholders,Compliance,Auditing & Quality Control in Clinical Research,Narrative Writing,Medical Reviews of ICSRs. @ Have Elevate and Expertise Addendum through EC,and Deliberately as well as Feasible Developed Skills on WHO international Drug Monitoring Program,ARGUS,ARISg Global Software,AERS ORACLE Database,CLINTRACE,AERS ORACLE Database,Pharmacovigilance,VIGIFLOW, Pharmacoepidemiology,Pharmacogenetics, Pharmacosafety,Pharmacoeconomics,Pharmacotherapy,Safety And Advanced Pharmacology.

Stackforce AI infers this person is a Healthcare and Pharmaceutical Quality Assurance Specialist with strong data analytics skills.

Experience: 2 yrs 6 mos