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Online Resumes with "medDRA"



Medical Scientist - 5 Years of Experience - Near 07302

SUMMARY: * Proficient in ARGUS Data Safety submission and Narrative Writing * Thorough understanding and knowledge of MedDRA coding, pharmacovigilance practices for both Clinical Trial and Post marketing AE reporting * Well versed with GVP-ICH guidelines * ECFMG certified medical graduate with strong clinical knowledge * Self-driven, highly motivated medical professional with excellent leadership and organizational skills *...

Tags for this Online Resume: Drafting, Coding, narrative wrirting, ARGUS, MedDRA, Medical Reviewer, Drug Safety, labeling, ICSRs

Featured Profile

Analysis of patient data through bedside care and pharmaceutical research for 35 years of exemplary work and experience

Objective * RN with 11 years of critical care experience with broad therapeutic clinical experience, expertise in development of processes for patient care, implementation and global training and project oversight. * Sixteen years of clinical research experience, which includes nine years in Drug Safety/Pharmacovigilance experience analyzing subject data. * Quality focused Data Management Associate Director of Clinical List...

Tags for this Online Resume: Business Development, Database, Development Activities, Infrastructure, Gastrointestinal, Intensive Care, Oracle, Critical Care, clinical, research, clinical trials, cro, pharmaceutical, Clinical

General - 7 Years of Experience

KEY QUALIFICATIONS: * COMPLAINTS & TECHNICAL SUPPORT SPECIALIST WITH 5+ YEARS OF PHARMACEUTICAL AND MEDICAL DEVICE INDUSTRY experience * 5+ years of experience with product complaints including experience with Global Customer Complaints (GCC), adverse events, and auditing of complaint records * Excellent knowledge of quality standards and regulations: FDA QSR 21 CFR 803 & 820, ISO Standards 9001 / 13485 / 14971, MDD 93/42/E...

Tags for this Online Resume: Complaints, Good Clinical Practices, Medical, Pharmaceutical, Support, Technical Support, Clinical Research, Project Management, Project Manager, Research

Clinical Research - 2 Years of Experience - Near 11418

SUMMARY: * 2 years of experience in the field of clinical data management, producing data review and management objects in various clinical studies and phases in daily bases. * Coding knowledge in MedDRA and WHO Drug systems, Sound knowledge in US FDA and ICH safety reporting advices * Thorough with project set up, quality assurance, data review, data analysis, database clean up and database closing using data management sy...

Tags for this Online Resume: Pricing, Protocol, Research, Data Entry, Data Management, Management, Project Planning, Quality Assurance, Services, Support

Clinical Research

SUMMARY OF EXPERIENCE I have experience in Clinical, in-house CRA as well as Data Management. I have Recruited Private Investigators for Cardiology studies and I have worked with Regulatory Documents. My area of Specialty is coding and In-house CRA. I have coded on Cardiology, Oncology, and Neurological, Antiviral, Respiratory and Diabetic studies. My Computer skills consist of Clintrial version 3.3 and 4.1, Windows 98, Win...

Tags for this Online Resume: Data Manager, Clinical Research, Research, Versioning, Coding, Business Objects, ICD-9, Medical, Medical Terminology, SAS

Pharmacist - 2 Years of Experience

Familiarity with FDA regulations, standard operating procedures (SOPs), good programming practices (GPP). * Utilized MedDRA and WHO-DRUG dictionaries in creating summary tables for Adverse Events and Concomitant Medications respectively.

Tags for this Online Resume: Information Technology, Coding, Data Migration, Distribution, Documentation, Programming, Project Management, Project Manager, SAP, SAS

Datawarehouse Designer - 11 Years of Experience - Near 28262

SUMMARY * ORACLE certified professional with 12+ years of hands-on experience in Oracle PL/SQL, DataModeling, Datawarehouse, ETL-Design, InformaticaPowerCenter9.x, SSIS, SSRS and Oracle Forms & Reports. * Strong Customer interaction skills and excellent expertise in Requirements gathering, Analysis, Estimation and Resource Planning. * Pretty good exposure in database design and extensive hands-on in handling ORACLE packages...

Tags for this Online Resume: Oracle, Database, Database Performance Tuning, Performance Tuning, Utilities, Business Analysis, Business Analyst, ETL, Extract Transform Load Tools, Shell Script, sql

Programmer Analyst

SUMMARY * 6 years of experience as a Statistical Programmer in Clinical trials of Pharma Industry. * Expertise in SAS programming features like BASE SAS, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/SQL, and ODS. * Skilled in generating reports featuring various SAS procedures, like Proc Report, Proc Summary, Proc Freq, Proc Mean, Proc Transpose, Proc sort, Proc Univariate, Proc Datasets, Proc Compare, Prco SGPLOT, and Proc SQL. * ...

Tags for this Online Resume: Base SAS, Macro (Predefined Code), Proc, SAS, SAS/STAT, Statistical Analysis, Structured Query Language, Data Analysis, HyperText Markup Language, Microsoft Excel

Admissions Director - 0 Years of Experience

SUMMARY * Pharmacovigilance Associate with over 2+ years of experience in Drug Safety and Clinical practice fields with clear understanding of EDC (Electronic Data Capture) * Experience in performing successful data management, triage, case entry, MedDRA, WHOdrug dictionaries, narrative writing, peer review, case follow-up, case review and report preparation * Performing Data entry and Quality check adverse event reports fr...

Tags for this Online Resume: Quality, General Practice, HYGIENE, Medical, Surgical, Acceptance Testing, Assessments, Business Intelligence, Coding, Database, healthcare

Licensed Nurse - 20 Years of Experience - Near 18974

I have extensive experience in writing clinical and regulatory documents in the Pharmaceutical industry which include regulatory and safety I have completed medical encoding (MeDRA), data and quality review management. My past experience included responsibilities for preparing safety sections within key documents such as Investigations Brochure, clinical study reports, writing safety narratives to be included in final stud...

Tags for this Online Resume: Management, Oncology, DS, Query, Medical, Oracle, Oracle Clinical, Database, Encoder, Risk Management