CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "AE reporting"

Manager Pharmacovigilance Quality Systems, Training and Standards

Obtain a position where I can maximize my BSN, RN nursing, pharmaceutical research and management skills. Apply my knowledge of AE reporting, quality assurance, risk management, auditing, clinical trial studies, regulatory reporting, employee supervision and development, and training experience.

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 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

Quality Assurance Specialist - 10 Years of Experience - Near 08817

Project Summary: ARISg is a Drug Safety System which provides all the functionality required to manage adverse event reporting and adverse reaction requirements of different authorities around the world, from case entry to automatic generation of submission ready adverse event (AE) reports including CIOMS I, Med Watch 3500A and many more. ARISg is an automated distributed system. In this system data would transfer to variou...

Tags for this Online Resume: Test, Regression Testing, Management, QTP, Test Scripts, Business Requirements, Framework, Coding, Functional Testing, Java Programming Language

Medical Scientist - 5 Years of Experience - Near 07302

SUMMARY: * Proficient in ARGUS Data Safety submission and Narrative Writing * Thorough understanding and knowledge of MedDRA coding, pharmacovigilance practices for both Clinical Trial and Post marketing AE reporting * Well versed with GVP-ICH guidelines * ECFMG certified medical graduate with strong clinical knowledge * Self-driven, highly motivated medical professional with excellent leadership and organizational skills *...

Tags for this Online Resume: Drafting, Coding, narrative wrirting, ARGUS, MedDRA, Medical Reviewer, Drug Safety, labeling, ICSRs