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Online Resumes with "pharmacovigilance"
Quality Assurance Director - 11 Years of Experience - Near 07076
SUMMARY Detail oriented and results focused professional with experience working in a global pharmaceutical company, research and development with multiple manufacturing sites and regulatory authorities worldwide. Possess clinical education, drug development and strong analytical background and solid understanding of the ICH, FDA, EMA Regulatory Guidelines as well as other regulatory body's guidelines and CMC requirements t...
Tags for this Online Resume: Good Laboratory Practices, Microsoft, Microsoft PowerPoint, Microsoft Visio, Policies and Procedures, Protocol, Quality, Quality Assurance, Research, Research and Development
Clinical Pharmacovigilance/Drug Safety - 8 Years of Experience - Near 19320
Clinical Pharmacovigilance/Drug Safety - 10 Years of Experience - Near 10591
To obtain a position as a Drug Safety Associate.
Ideal Companies: Regeneron, Pfizer, HHC NYC
Tags for this Online Resume: Distribution, Training, Data General Nova, Chemistry, High Performance Liquid Chromatography (HPLC), PEDIATRIC, Inventory, Inventory Control, Cancer, Chemotherapy, oncology, clinical, pharmaceutical, gcp, ich, protocol, phase, sas
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
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
Clinical Pharmacovigilance/Drug Safety - 15 Years of Experience - Near 19355
Tags for this Online Resume: Medical, Medical Terminology, Nursing, MDR, Medical Devices, Root Cause Analysis, Oncology, Orthopedic, Orthopedics, pharmaceutical
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
Life Scientist - 20 Years of Experience - Near 94002
Accomplishments: * Actively consulting on, discovery and development of Antibody Drug Conjugates (ADCs) * Actively consulting on, small molecules process optimization, scale-up and regulatory aspects * Sepsis diagnostic kits (mAb based) business to Asia for development, manuf. and marketing. Consulting and Project Management * API Process Dev - (Malvern, PA) DP Formulations - Horizon Therapeutics (CA) * Duexis Tabs launched...
Tags for this Online Resume: Cancer, Adc (Advance Data Comm), Consulting, Outsourcing, Pharmaceutical, Management, API, Manufacturing, Application Program Interface, pharmaceutical, biotech, drug development, operations, regulatory
Clinical Pharmacovigilance/Drug Safety - 2 Years of Experience - Near 27607
Summary My goal is to have a challenging career in the Biotechnology industry. I would love to expand my skills and knowledge in the industry. I have experience in warehouse setting my production was the highest in my department. I was awarded almost every month for my outstanding work. I was also in the medical profession, so I know how important it is to place the client's needs first and foremost.
Tags for this Online Resume: HYGIENE, Biotechnology, Complaints, Home Care, Home Health, Housekeeping, Information Technology, Management, Manufacturing, Medical, pharmaceutical
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
Regulatory Affairs Specialist - 16 Years of Experience - Near 19464
An accomplished records and information management specialist with proven skill set including 16 years’ experience within records retention and information management. Focus on health authority audit preparedness, compliance, security, and lifecycle management requirements of key company proprietary media encompassing all GXP documentation. Actively liaise with internal areas and external groups including CMOs and CROs to ...
Tags for this Online Resume: Filing, Management, Quality, Quality Assurance, Quality Control, Retention, Document Management, Documentation, Information Technology, Records and Information Management, Regulatory, Operations, Record Coordinator, Compliance, Regulatory Operations
Clinical Pharmacovigilance/Drug Safety - 5 Years of Experience - Near 77030
Summary of Professional Experience Physician surgeon scientist in the field of cell biology, with emphasis on the molecular biology of neoplasms, cell signaling, target identification and cancer biomarkers. Solid experience in ex vivo analysis of tumor cells by FACS, IHC and ELISA as well as maintaining and cultivating cells, coordinating in vitro research and managing a wide range of projects in fast-paced environments. Pr...
Tags for this Online Resume: Cancer, Cellular, Collection, Dos, ELISA, Gynecology, Leadership, Medical, Microsoft DOS, Monitoring, oncology, clinical, phase, trial, pharmaceutical
