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Online Resumes with " Adverse Events"
Clinical Regional Monitoring - 20 Years of Experience - Near 18929
Seeking an opportunity with a Pharmaceutical, Biotechnology company or CRO as a Senior Lead Clinical Research Associate, Lead CRA, CRA Manager/Trainer (Mentor) and/or CRO Oversight Monitor to employ my 27 years of clinical research monitoring, management skills and CRA mentoring as well as19 years of Respiratory/Pulmonary and Cardiopulmonary critical care clinical medicine. Clinical Research Experience: Projects/Therapeutic...
Tags for this Online Resume: Pharmaceutical, Clinical Research, Research, Rheumatology, Biomedical Industry, Pharmaceutical Industry, Cardiology, Critical Care - Neurology, Critical Care - Respiratory, Neurology, oncology, clinical, phase, gcp, protocol, trial, ich
Director of Quality & Regulatory- 22 Years of Experience - Near 45142
Summary Twenty-two years in the Medical Device Manufacturing Field, including 16 years of Director level experience in Quality Managements Systems, Regulatory Affairs and Quality Assurance/Quality Control Activities. Knowledge and professional experience in the following areas: Quality, Engineering and Manufacturing Implemented practical oversight of the following: * ISO13485 * ISO9001 * 21CFR820 (FDA) * ISO14971 Risk Manag...
Ideal Companies: A company with suability, growth and development of their employees.
Tags for this Online Resume: Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory
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
Drug safety physician, PA/NJ
Seeking a medical director drug safety position to best utilize my over 10 years experience in pharmaceutical industry.
Tags for this Online Resume: Risk management plan, PSUR, Medical review, Safety management meeting, pharmacovigilance/drug safety, adverse events/adverse drug reactions
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
Clinical Research - 5 Years of Experience - Near 19128
SUMMARY * Project coordination, document management and coordination experience in a clinical health environment in pharmaceutical industry. Worked for Spark Therapeutics, Baxter, Execupharm, United BioSource (an Express script company) and Liquent (a Parexel Company) * 3 + years of experience in Regulatory Affairs supporting the compilation of regulatory submission and assisting with the publication those submissions using...
Tags for this Online Resume: Documentation, Microsoft Excel, Microsoft Office, Microsoft Outlook, CVS, Distribution, Document Management, Documentum, Documentum (Wkflow Sw), Financial
Clinical Regional Monitoring - 3 Years of Experience - Near 0000
PROFESSIONAL SUMMARY Clinical Research Professional with various project experience from concept to development. Talents include in-depth knowledge of ICH guidelines SAE reporting and GCP auditing. Integral team-player with excellent communication skills CORE QUALIFICATIONS * Patient Recruitment & Screening * Detailed Documentation * Serious Adverse Event Reporting * Communicating with IRB for study proposal, approval and u...
Tags for this Online Resume: Clinical Research, Data Entry, Research, Audit, Communication Skills, Compliance, Documentation, Excellent Communication Skills, Good Clinical Practices, ICH
Regional Home-Based CRA
Tags for this Online Resume: oncology, phase, clinical, trial, gcp, protocol, pharmaceutical, Cardiovascular, CRO, Neurology, Bone, immunotherapy, monitoring, Initiation, close-out, Remote, query, onsite, SOP, ICH, GCP, investigator, IRB, sponsor, CTMS, CNS, Endocrinology, Haematology, ICF, Informed Consent, EDC, SDV, InFORM, MediData Rave, eTrial, eDiary, MedWatch, Adverse Event AE, SAE, 1572 Statement of Investigator, IB, Trip Report
Clinical Research Associate
Proficient in clinical nursing practice Excellent interpersonal relationship building abilities Strong verbal, written and computer skills Proven problem solving and decision making ability
You shouldn't have to read my entire resume to know I'm the one!
I absolutely enjoy what I do and look forward to work every week. I know there will be challenges and problems that my team and I will have to solve. I enjoy this career because every day is different. Every study requires a different amount of care and expertise/experience. I love the organization that comes with this career. I love having my own studies and organize documents according to company SOP as well as my own way...
Ideal Companies: Any Biopharma Company (start-up, or young companies) in Phase 1 or 2 of their studies
Tags for this Online Resume: Instant Messaging, Data Analysis, Document Management, Good Clinical Practices, Good Laboratory Practices, Management, Medical, Medical Terminology, Microsoft, Microsoft Excel, Data Entry, Site Feasibility, Trial Master File Audit, Trial Master File, Routine Monitoring Visits, Bilingual, IWRS Systems, DSMB, analysis of PK data from different generations of Japanese subjects, Receiving Plasma samples and storing them in freezers, Urine collection and UA testing, Phlobotemy, ECGs, Dosing, Writing Visit Reports, Query data sheets, Resolving Queries within the SOP allotted time frame, Pippetting Fluids and shipping off with appropriate courier., CRA visit matrixes, Reporting numbers and statistics to Project Manager and Operations Manager, Reviewing Source Documents and making original source documents according to procedures in the protocol, Protocol review sessions, QA sessions daily with a volunteer from each department to go over daily data and tasks to make sure none were missed, Call subjects and perform AE checks according to timelines on protocol, Send critical documents to sites directly or through CRAs as demanded., Make progress matrices of site visits and site reports, Send reminder emails for upcoming visits for CRAs and internal deliverables, Coder
Contract Medical Writer
Summary Work Experience: Strong background in medical writing and biotechnology product and services development, with a solid publication record in the peer-reviewed medical literature in addition to biotechnology analyst articles-an unusual combination of medical writing expertise, analytical skills, data analysis, management experience, and medical knowledge. Participate in pre-clinical, clinical, and commercial research...
Tags for this Online Resume: Business Development, Cancer, Clinical Research, Medical Writer, regulatory science, biologics, drugs, medical device
In Between - 5 Years of Experience - Near 500081
Career Summary * SAS Certified Base for SAS9 with more than four years of experience. * Worked on different Phases of clinical trials and I have experience in programming, SDTM, ADAM and reporting in Clinical Research using SAS environments. As a Clinical SAS * Worked on Various Complicated SDTM domains like LB, MO & OE for ophthalmoscopy studies * Understanding of the study Documents and Data (e.g. Study design and objecti...
Tags for this Online Resume: A SERIES, Active Directory Application Mode (ADAM), Base SAS, Cardiology, Clinical Research, Data Management, Documentation, Generate Reports, HyperText Markup Language, Macro (Predefined Code)
