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Online Resumes with "DSUR"



Pharmacovigilance/ Risk Management Specialist

To leverage my Pharmacovigilance experience and knowledge of guidelines and regulations to garner greater technical writing and scientific expertise, to contribute continuously to flourish my organization. To acquire great leadership skills in a professional environment with a challenging position in the area of Pharmacovigilance, while being resourceful, innovative, flexible and to produce world class results.

Ideal Companies: Bristol Myers Squibb, Regeneron, Pharmacyclics, Gilead, Amgen, Johnson and Johnson, Celgene, UCB, Onyx, Novartis,

Global Drug Safety professional

Drug safety, medical monitoring professional with 7 years in drug safety and over 15 years in clinical research, pursuing challenging drug safety lead position where my education, experience and knowledge can be implemented and utilized accordingly

Tags for this Online Resume: NJ, Drug Safety Director/Medical Monitor, Signal detection, causality relatedmess assesment and determination, SAE reports and line listings, RMP, , coding review and approval, approve, protocol, IB, DSUR, PSUR, SOP's, etc, Assist with BLA, IND, MAA in EMEA , DSMB, KOL, Site and vendor selection.

Clinical Research - 10 Years of Experience - Near 18901

Summary: * Several years of clinical experience in the industry with excellent knowledge of drug development in different therapeutic areas including oncology, immunology, vaccines, metabolism and biosimilars. Solid clinical practice experience. * Many years of Drug Safety, pharmacovigilance, risk management and epidemiology experience * Experience interfacing with health authorities (worldwide), institutional review boards...

Tags for this Online Resume: Oncology, Protocol, Regulatory Affairs, Risk Assessment, Management, Risk Management, Risk Management Activities, Complaints, Documentation, Hematology, Medical Affairs, Clinical Development

Clinical Pharmacovigilance/Drug Safety

SUMMARY * Health care professional with extensive years of experience with Pharmaceutical/Medical device industries as Medical coding and Pharmacovigilance professional in the processing and medical review/evaluation of reports related to investigational and marketed products in the following therapeutic areas: Oncology, Neurosciences, Cardiovascular, Pain/Inflammation, Rheumatology and Diagnostic products. * Responsible fo...

Tags for this Online Resume: Management, Process Improvement, Coding, Regulatory Reporting, Audit, Cardiology, Compliance, Metrics, Oncology, Data Entry

Clinical Pharmacovigilance/Drug Safety - 10 Years of Experience - Near 19440

Summary Clinical Scientist/Clinical Data Analyst/Clinical Data Management/Project Coordinator/GLP auditor/Research Biologist with over 15 years experience in the pharmaceutical industry. Authored/QC review of protocols, protocol amendments, protocol clarification letters, informed consent forms, risk language, periodic safety reports (PSUR, DSUR, QSR), investigator brochures, medical monitoring plans, clinical SAE narrative...

Tags for this Online Resume: Protocol, Oncology, Audit, Monitoring, Critical Care - Neurology, ICH, Neurology, Quality Assurance, Test, Data Quality

Team leader-8 year experience-Pune

Seeking a challenging role in the field of Pharmacovigilance & Clinical Research that encourages continuous learning and creativity which provides exposure to new ideas and stimulate personal and professional growth. To utilize my abilities for professional growth while being resourceful and innovative to achieve the organizational goals and targets. Pharmaceutical Educational Credential: M. Pharmacyin Pharmacology from Dr....

Tags for this Online Resume: Audit, Business Intelligence, Compliance, Computer Aided Software Engineering, Data Entry, Database, Evaluate, Extensible Markup Language (XML), Internet, Joint Ventures, Pharmacovigilance, Drug safety, Aggregate reports writing, ICSRs, narrative writing, ARGUS, ARISg, PSUR, PBRER, PADER, RMP, DSUR, DATA ENTRY