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Online Resumes with "postmarketing"



Quality Systems Manager/Director

Skilled leader with expertise in quality assessment, complaint management, both pre- and post-market product approval, associated regulatory reporting compliance, e.g., pharmacovigilance, field corrective action (FCA), and managing both internal and external quality assessment of operations. Designed, developed, reviewed and implemented quality, regulatory and operational systems. Developed and defined monitored account ...

Tags for this Online Resume: quality systems, regulatory reporting, quality assessment, field corrective action, complaint management, quality assurance

Clinical Research - 7 Years of Experience - Near 94134

I am a Senior Drug Safety professional, board-certified in Ob-Gyne with 20 plus years career in the pharmaceutical/biotech industry. Experience with phase I - III clinical trials and post-market drug safety in US and international setting. Created full-service, compliant Drug Safety department beginning from phase III through approval and post-market surveillance (various therapeutic area targeted therapy). Experience with ...

Tags for this Online Resume: Pharmacovigilance, Drug Safety, Clinical Research, Clinical Project Management, Medical Affairs, Clinical Development

Featured Profile

Professional Researcher - 10 Years Experience

PhD with documented success and experience in a diverse range of fields including academia, pharmaceuticals, and the medical device industry. Excellent writing, presentation and data analyses skills. Strong interpersonal skills with a remarkable ability to communicate scientific information to a diverse audience. Motivated by systems to improve human health and patient care.

Ideal Companies: Stryker, Johnson and Johnson, Glaxo Smith Kline

Tags for this Online Resume: Research, Infectious Diseases, Statistics, Medical Devices, Spine, Orthopedics, Sales, Pennsylvania, Clinical Research Manager, Biology, Immunological Assays, Client Relations, Social Media, Large-Scale Studies, Vaccines, Market Analysis, Event Planning, Sales Cycle Management, Data Analyses, qPCR, Genome Sequencing, Global Research, Journal Publications, Published Writer, Media Relations, Presenatations, Team Leadership

Clinical Research

SUMMARY: * POST-MARKETING REPORTING: Vast clinical experience in reporting post-marketing events in the pharmaceutical industry. * CDM: Acquaintance on clinical data management, pre-clinical and clinical trials (Phase I, II, III and IV) * CLINICAL WRITING & DOCUMENTATION: Create clinical project documents according to the protocol, including, but not limited to, source documentation forms and guidelines, monitoring Standard...

Tags for this Online Resume: Ipc, Planning, Protocol, Research, Reuters, Business Planning, Coding, Documentation, Immunology, Information Technology

Clinical Research - 2 Years of Experience - Near 77449

HIGHLIGHTS OF QUALIFICATIONS: * RN with close to 2-years experience in clinical trials monitoring * Knowledgeable of clinical trial procedures and approval processes. * In-depth knowledge of ICH GCP guidelines and FDA regulations * Conversant with Design and Review of case report forms (CRF) * Conversant with Site Monitoring visits (PSVs, SIVs, IMVs and COVs) to meet study expectations. * Clinical and post-marketing safety ...

Tags for this Online Resume: Direct Patient Care, DRESSING CHANGES, Medical, Patient Care, Suctioning, Surgical, Wound Care, Acquired Immune Deficiency Syndrome (AIDS), HIV, Monitoring

Clinical Pharmacovigilance/Drug Safety

SUMMARY * Medical degree with over 25 year experience in clinical and drug safety surveillance setting within the pharmaceutical and Biopharmaceutical industry (Example: Amgen, Alza Corporation, Idec, Biogen Idec, Elan, Genentech, Roche, Sharing AG, Wyeth, Élan Pharmaceuticals, Actelion Pharmaceuticals) * Advance knowledge of US and international Safety regulations and Safety assessment of Marketed and Investigational drugs...

Tags for this Online Resume: Training, Data Entry, Coding, Policies and Procedures, Clinical Research, Data Management, Immunology, Management, Oncology, Query

Quality Assurance Director - 4 Years of Experience - Near 08736

Accomplishments: * Led a group of 6 employees in a 24-person firm * Led a group of employees and consultants to file Icotinib IND to FDA for NSCLC * Directly handled post - IND interactions/questions with FDA * Lined up Accenture to handle eCTD publishing and submissions * Led a group to assemble and file Briefing Packages to UK, Canada, Australia and Singapore Regulatory Authorities set up and presented face-to-face meetin...

Tags for this Online Resume: Regulatory Affairs, Advertising, Business Plan, Filing, Assessments, Business Development, Chemistry, Consulting, Due Diligence, Integrate

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

Not Listed - 20 Years of Experience - Near 91740

SUMMARY An analytical and detail-oriented healthcare professional, with extensive experience in nursing, biotechnology, regulatory compliance, global safety, pre- and post-market studies, research and development, clinical trials and FDA compliance. Utilizes exceptional organization and communication skills to consistently set and meet high-quality standards. Possesses a proven ability to utilize a cross-functional skill se...

Tags for this Online Resume: Complaints, Coding, Compliance, Manufacturing, Medical, Oncology, Pharmaceutical, Policies and Procedures, Quality, Quality Assurance

Clinical Pharmacovigilance/Drug Safety - 17 Years of Experience

Summary: Over 16 years of Drug Safety experience that includes Global Drug Safety project management in Clinical Research Organization and Sponsor (Pharmaceutical) environments. Experienced clinical trial and post-marketing studies. Participated in stand-alone and full service studies as Global Drug Safety/Pharmacovigilance Lead in addition to mentoring and managing a team of junior drug safety associates.

Tags for this Online Resume: Oncology, Hepatitis, Query, Cardiovascular, Documentation, Infectious Diseases, Quality, Quality Assurance, Quality Control, Data Entry

Health Technologist - 14 Years of Experience - Near 95010

SUMMARY Medical device industry veteran with experience with product development, clinical strategies implementations, regulatory approvals, clinical marketing and market development. Recognized professional who is persistent and thrives in a multi-level, fast-paced environment. Keen, innovative and dedicated individual with strong ethical and moral values. Creative thinker with the ability to challenge norm and tackle unre...

Tags for this Online Resume: Clinical Research, Research, Internet, Management, Project Management, Vendor Management, Clinical Affairs, Data Analysis, Team Management