Case processing quality review. Maintain and manage a system for reconciliation of ADE cases, PQCs and MIs received at US Drug Safety. Manage execution and maintenance of Safety Data Exchange Agreements (SDEAs) Receive incoming calls related to Adverse Drug Event/incident, Product Complaint information Data entry and process of adverse drug events (ADE) into Argus system for submission to regulatory authorities when required. Exchange of Safety Information with Business Partners Perform follow-up calls
Kelly Healthcare Resources|Lake Forest, IL, 60045|
Kelly Clinical Research is currently seeking candidates with experience in Global Product Safety and Complaints for our customer in Northern Illinois. This is a 6-12 month contract opportunity. The GPSC Associate will be responsible for managing a complaint through its entire life cycle from triaging the initial phone call, making the decision on appropriate action, entering the complaint into the tracking system, investigation, regulatory reporting and ultimately closure. This position requires candidates
Sr Drug Safety Specialist Job Type: Regular Full-Time Location: Seattle, WA Job Description: Dendreon is seeking a Senior Drug Safety Specialist who will leads the compilation and review of the safety sections of periodic regulatory reports including IND annual reports, clinical study reports and the BLA integrated summary of safety section. The successful candidate should have strong attention to detail and have experience solving complex problems in creative and effective ways. General Summary: Ensures
Kelly Healthcare Resources|Lake Forest, IL, 60045|
Kelly Clinical Research is currently seeking candidates with experience in Global Product Safety and Complaints for our customer in Northern Illinois. This is a 6-12 month contract opportunity. The GPSC Associate will be responsible for managing a complaint through its entire life cycle from triaging the initial phone call, making the decision on appropriate action, entering the complaint into the tracking system, investigation, regulatory reporting and ultimately closure. This position requires candidates
The person hired for this position will be responsible for processing serious adverse events in oncology clinical trials, focusing on the evaluation and reporting of cases in accordance with global safety regulations, departmental standard operating procedures and company policies. This individual will track cases from receipt to closure, perform verification of safety data and will utilize clinical/pharmacovigilance judgement in coding of serious events and synthesizing complex clinical information into accurate
Kelly Scientific Resources|Collegeville, PA, 19426|>5
Every day, Kelly Scientific Resources (KSR) connects scientific professionals with opportunities to advance their careers. KSR is the first and largest scientific staffing company in the world, and we currently have an exciting Medical Pharmacovigilance Associate position available northwest of Philadelphia, PA. A Medical Pharmacovigilance Scientist applies their skills, knowledge, and experience to contribute to the overall safety surveillance of marketed and investigational products. The principle responsibilities
A Worldwide Clinical Research Organizaion (CRO) is searching for an experienced Clinical Drug Safety Specialist located in their Raleigh/Durham, RTP, NC office location. Job duties and responsibilities will include but are not limited to the below criteria. Job Description: The function of the Drug Safety Specialist includes overseeing the case handling and processing of clinical trial and spontaneous postmarketing events, assisting in the management and analysis of safety data with a particular emphasis on
A Clinical Research Organization is searching for an immediate Drug Safety Specialist out of their office located in Raleigh-Durham, NC. A nursing or pharmacist background is preferred but not required for this opportunity. Please find details below for this contract opportunity. Description: Serve as Pharmacovigilance (PhV) team member and project team lead, with supervision. Assist PhV management in building a productive team environment among assigned staff and between other sections and departments. Obtain
Position Drug Safety Specialist Duration: 6+ months Location: MORRIS PLAINS, NJ Responsible for the receipt and data entry of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents to ensure compliance with worldwide safety regulations and corporate policies Principal Responsibilities include: Data management, report preparation and appropriate dissemination of spontaneous non- serious and serious adverse event information
Job Description The responsible person will serve as safety lead on assigned clinical study teams and will contribute to the development of study-related documents as well as the review and analysis of safety information. This individual will be responsible for ongoing review of accumulated safety data and assist in the development and maintenance of accurate risk profiles for assigned products. Drug Safety Specialist / Manager Duties and Responsibilities Prepares relevant safety documents for company management
POSITION SUMMARY: Directly responsible for ensuring that adverse events are processed, analyzed and reported according to Corporate SOP's, Local Working Instructions and local regulatory requirements. Responsible for distribution and retrieval of data to internal and external customers as needed for analysis and compliance with regulations. Serve as point of contact with clinical team in areas of adverse event process. DUTIES & RESPONSIBILITIES: - Assists in developing and/or implements customized
Frankel Staffing Partners|Research Triangle Park, NC|3
Our client, a RTP-based specialty pharmaceutical firm, is experiencing significant growth and is looking to bring on a very sharp and knowledgeable Safety professional for key role within its Safety function. Role will require experience with post-marketed products. Seek a high caliber candidate who enjoys a growing dynamic setting. Responsibilities will include all tasks related to the collection, processing, reporting and analysis of adverse events for marketed products. The successful candidate will ensure
A Worldwide Pharmaceutical Company is searching for an experienced Clinical Drug Safety Specialist located in their Raleigh/Durham, RTP, NC office location. Job duties and responsibilities will include but are not limited to the below criteria. Job Description: The function of the Drug Safety Specialist includes overseeing the case handling and processing of clinical trial and spontaneous postmarketing events, assisting in the management and analysis of safety data with a particular emphasis on support to clinical
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 60 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology and hematology. If you d like to join a company where you can make a difference, please consider the Celgene family. The Drug
Business Title Drug Safety Support Specialist Requisition ID 19028BR Job Category Biotechnology/Pharmaceutical Locations Australia, Sydney Shift 1 Job Posting Covance is one of the world's largest and most comprehensive drug development services companies, with annual revenues greater than $1.5 billion and offering drug development solutions ranging from pre clinical right through to commercialization. Covance's consistent growth, size, comprehensive drug development services offerings, and geographic spread
Valeant Pharmaceuticals|Redwood City, CA, 94061, USA|1-3
Senior Drug Safety Specialist Job ID: 1660 Location: US-CA-Redwood City Category: Research & Development/Medical Affairs Pos. Type: Full Time More information about this job: Overview: A Drug Safety Specialist 2 is expected to supervise for quality control the work of less experienced staff in the experimental and postmarketing pharmacovigilance areas. That individual shall perform review of safety information on Valeant experimental and marketed drug products to ensure accuracy of MedDRA coding, and as needed
INDUSTRY-LEADING GLOBAL BIOTECH SEEKS DRUG SAFETY SPECIALIST Our client, one of the largest and most innovative global biotech companies in the industry, is looking for an experienced drug safety professional to manage safety data within their central safety database covering both pre- and post-market activities. The position is based in Summit, NJ and will report to the senior manager case management. If you are a drug safety professional and would like to enhance your career, please email a Word document
INDUSTRY-LEADING GLOBAL BIOTECH SEEKS DRUG SAFETY SPECIALIST Our client, one of the largest and most innovative global biotech companies in the industry, is looking for an experienced drug safety professional to manage safety data within their central safety database covering both pre- and post-market activities. The position is based in Summit, NJ and will report to the senior manager case management. If you are a drug safety professional and would like to enhance your career, please email a Word document
INDUSTRY-LEADING GLOBAL BIOTECH SEEKS DRUG SAFETY SPECIALIST Our client, one of the largest and most innovative global biotech companies in the industry, is looking for an experienced drug safety professional to manage safety data within their central safety database covering both pre- and post-market activities. The position is based in Summit, NJ and will report to the senior manager case management. If you are a drug safety professional and would like to enhance your career, please email a Word document
INDUSTRY-LEADING GLOBAL BIOTECH SEEKS DRUG SAFETY SPECIALIST Our client, one of the largest and most innovative global biotech companies in the industry, is looking for an experienced drug safety professional to manage safety data within their central safety database covering both pre- and post-market activities. The position is based in Summit, NJ and will report to the senior manager case management. If you are a drug safety professional and would like to enhance your career, please email a Word document
MR - Klein Hersh International|Newark, NJ, 07101|2
INDUSTRY-LEADING GLOBAL BIOTECH SEEKS DRUG SAFETY SPECIALIST Our client, one of the largest and most innovative global biotech companies in the industry, is looking for an experienced drug safety professional to manage safety data within their central safety database covering both pre- and post-market activities. The position is based in Summit, NJ and will report to the senior manager case management. If you are a drug safety professional and would like to enhance your career, please email a Word
MR - Klein Hersh International|Princeton, NJ, 08540|2
INDUSTRY-LEADING GLOBAL BIOTECH SEEKS DRUG SAFETY SPECIALIST Our client, one of the largest and most innovative global biotech companies in the industry, is looking for an experienced drug safety professional to manage safety data within their central safety database covering both pre- and post-market activities. The position is based in Summit, NJ and will report to the senior manager case management. If you are a drug safety professional and would like to enhance your career, please email a Word
MR - Klein Hersh International|Philadelphia, PA, 19019|2
INDUSTRY-LEADING GLOBAL BIOTECH SEEKS DRUG SAFETY SPECIALIST Our client, one of the largest and most innovative global biotech companies in the industry, is looking for an experienced drug safety professional to manage safety data within their central safety database covering both pre- and post-market activities. The position is based in Summit, NJ and will report to the senior manager case management. If you are a drug safety professional and would like to enhance your career, please email a Word
MR - Klein Hersh International|New York, NY, 10001|2
INDUSTRY-LEADING GLOBAL BIOTECH SEEKS DRUG SAFETY SPECIALIST Our client, one of the largest and most innovative global biotech companies in the industry, is looking for an experienced drug safety professional to manage safety data within their central safety database covering both pre- and post-market activities. The position is based in Summit, NJ and will report to the senior manager case management. If you are a drug safety professional and would like to enhance your career, please email a Word
Patni works with nearly fifty pharmaceutical, biotechnology and medical device firms to streamlines business processes, increase productivity, and minimize risk in the drug safety and clinical realm. Come join our team to help life science companies adhere to the stringent timelines in reporting adverse events and improve the efficiency of pharmacovigilance operations. Please email resumes to LSresumes@patni.com stating AECP as the email subject line. Position Overview: - Collect information
Definition: The completion of full case information on the database, culminating in Quality Review to ensure accuracy and completeness. Activities Include: - Triage of incoming cases to determine seriousness for prioritization of daily workflow (to be discussed re triage specialist) - Confirmation of Safety Coordinator case registry data - Database searches as necessary - Completion of literature searches as necessary - Completion of remaining case data entry, including narrative
Title Drug Safety Specialist/Manager Department Drug Surveillance and Information Job Type Full Time Job Category Biotechnology and Pharmaceutical Location Connecticut-Danbury/Bridgeport City Ridgefield Our Culture In a world where business is driven by short term financial goals, Boehringer Ingelheim Corporation is truly a company with a different philosophy. Although we are one of the largest and fastest growing pharmaceutical companies in the world, we have been able to maintain a dedication to our values
Drug Safety Specialist II Job ID: 19573 # Positions: 1 Location: US-NJ-Morris Plains Experience (Years): .. Posted Date: 11/25/2008 Recruiter: Latish Salian Apply for this job: Your application choices are: Apply for this jobonline Send your resume as an attachment viae-mail Refer someone you know More information about this job: Responsibilities: Responsible for the receipt and data entry of adverse event reports following Company Standard Operating Procedures, internal business practices and regulatory