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Online Resumes with "PSUR"
Clinical Research Associate - 5 yearsexperience - Regulator Affairs
I am currently looking for an appropriate job opening in a Research Institute. I have five years experience as a Clinical Research Associate (as Regulatory Officer and Medical Writer). I had been working with reputed pharmaceutical companies in India. I have led a team of Medical writers and as a part of them, I have written Clinical and Pre-clinical overviews on more than 100 molecules for regulatory dossier submission ...
Tags for this Online Resume: Protocol Development, Clinical study report, Clinical study audit and monitoring, Regulatory dossier submission, RMP, PSUR, Leaflet, Regulatory queries
Sr. Clinical research Associate/ Director of clinical research
Can undertake most of the tasks and works independently. Very much focussed on the timelines and quite goal tending. Willing to help others in their prioritized tasks. Excellent planning, design and implementation. Highly experienced in writing reports and data analyses.
Ideal Companies: Pharmaceutical industries, Biotech companies, Research institutes, hospitals and for profit mid to large companies.
Tags for this Online Resume: Director of clinical research, Manager of drug safety, Senior clinical research associate, Regional clinical research associate
Senior Regulatory Writer (17 years experience)
I am seeking to end my present consulting status and return to an in-house position where continuity of projects is more realized. I have over 15 years experience writing regulatory medical documents that comprise CFR21 356h NDA/BLAs and eCTDs deliverables to the FDA/EU/Canadian regulatory authorities. I have written approximately 85 CSRs and can confidently say that ~40 of these were NCEs, early phase I/II and some pha...
Tags for this Online Resume: Regulatory Medical Writer Manager level
Drug safety Professional
Seeking an opportunity to work with a view to utilize my interest, credentials and work experience in the field of medical towards professional growth and development.
Tags for this Online Resume: Drug Safety, MedDra coding, WHODD Coding, Adverse Event Processing, Safety Narrative writing, PSUR & PADER draft preparation
Drug Safety/Pharmacovigilance Physician- 8 years drug safety experience
I am a Physician with 8 years of drug safety/pharmacovigilance experience, knowledgeable in regulatory affairs for drugs, biologics and medical devices with diverse background in analysis, processing and medical review of adverse events (individual and aggregate reports) and coding according to MEDRA.
Tags for this Online Resume: Pharmacovigilance, MEDRA, Argus, Drug Safety, Drug/Bilogics/Medical device regulations, PSUR/PBRER/PADER
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,
Medical reviewer, Chicago
CAREER SUMMARY Self-motivated, detail-oriented reliable drug safety physician with 8-year-experience in pharm/biotech industry with good knowledge of global pharmacovigilance (PV) regulations, clinical medicine and bio-medical research; led and conducted single case (ICSR) medical review in therapeutic areas (TA) oncology, medical assessments, proactive signal detection and aggregate safety analysis ...
Drug Safety Physician, Medical Monitor, 11 years experience
An accomplished individual offering long-term experience in the pharmaceutical industry. My areas of expertise include Medical Affairs, Drug Safety, Medical Monitoring, and Clinical Research Associate. Additionally, I possess 18-year medical practice including head and neck Oncology.
Tags for this Online Resume: Medical Monitor, PSUR, GCP/ICH, CRA, Remote, MedDRA coding, Adverse Events, Risk Management Plan, SMQ
Clinical Data Management - 11 Years of Experience
I am seeking a research and/or academic teaching position in Cincinnati, Ohio and surrounding areas. My objective is to contribute my scientific medical,academic nursing and psychology research and teaching skills, knowledge and experience towards positive outcomes in research in these areas and related fields.
Tags for this Online Resume: Oncology Nursing, Oncology Nursing, Oncology Nursing, Oncology Nursing, Publication, Oncology Research, Nursing Research , PSUR Construction, Clinical Protocol Assessment, Legal Case Review/Reporting, Legal Case Review/Reporting, Serious Spontaneous Adverse Events, Consumer Adverse Reports
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
Physician
Profile Experienced, highly motivated healthcare professional with notable accomplishments in clinical and basic research achieved in both academic and pharmaceutical industry arenas. Broad knowledge of all aspects of therapeutic product development. Extensive experience in strategizing and implementing global clinical research and development programs. Known for particular expertise and success in early clinical developmen...
Tags for this Online Resume: Clinical Research, Research, Cardiovascular, Endocrinology/Metabolism and Internal Medicine, Patient Care, Clinical Pharmacology, Protocol design/ Medical Monitoring, Budget Review, Budgeting, Board Certified/ Internal Medicine, Subspecialty-Endocrinology/Metabolism, Pharma/Clinical Research - Phase 1,2,3, Pennsylvania/ Pfizer (formerly Wyeth), Phase 1 and 2
