Leigh Mangum Email & Phone Number

Cincinnati, Oh, Us

Raleigh, North Carolina, Us

Durham, North Carolina, Us

Durham, North Carolina, Us

Raleigh, North Carolina, Us

• Interfaces between Company, sponsors, vendors, and other departments in the area of safety and pharmacovigilance.• Processes Adverse Events (AEs)/Endpoints according to Standard Operating Procedures (SOPs) and project specific safety plans.• Triages AEs, evaluates AE data for completeness, accuracy, and regulatory reportability. • Enters data into safety/adjudication database.• Performs Quality Control (QC) of entered data/endpoint dossiers. • Codes events, medical history, concomitant medications and tests.• Compiles complete narrative summaries.• Discerns what information requires querying and interacts closely with study monitors, investigative site personnel, and sponsor representatives until all follow-up information is obtained and queries are satisfactorily resolved.• Participates in generation of reports to the sponsor and regulatory authorities; ensures timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.• Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases.• Assists safety project lead/endpoint manager in the preparation of a safety management plan. • Distributes all required periodic reports for both clinical and post-marketing projects.• Ensures all aspects of the Company’s safety data collection and processing are consistent with current industry practices and meet all pertinent domestic and international regulatory requirements.• Maintains current professional knowledge in fields of safety management, coding, computer science, quality assurance, regulatory affairs, and applicable areas of medical sciences to serve as a basis for providing “value added” expanded company services to all appropriate clients.• Maintains understanding of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process.

Ashby-De-La-Zouch, Leicestershire, Gb

•Collaborates with Business Development in the preparation, review and execution of proposals, contracts and other documents; maintain central files and coordinate status of all documents/contracts. •Review, maintain and manage information in customer relationship management and work management databases (Salesforce.com) according to DSA standards and run reports as needed. •Maintain document control process for Business Development & Marketing files and materials. •Conduct industry conference research, implement plans, tracking, and follow-up reporting; coordinate registration and travel for DSA attendees. •Coordinate and assist with DSA Business Development/Marketing events. Collaborate with the team to track timelines and perform tactical assignments. •Collaborate with Marketing & Business Team members to plan, develop and produce promotional

Ashby-De-La-Zouch, Leicestershire, Gb

•Extract dates from source documents and apply timelines to all applicable reports/documentation received.• Interpret data from report sources and determine important case factors such as seriousness, expectedness, drug-relationship, etc.• Extract adverse event data from various clinical trial cases and spontaneous sources.• Track and record all adverse event reports received from individual clients (via hardcopy sources and/or electronic sources).• Assess initial reports for reportability, and delivers case files to the appropriate Case Manager for initial assessment.•Exhibit a working knowledge of DSA clinical and spontaneous case processing procedures.•Assist in providing submission/project work for the following: IND Annual Reports, Periodic Safety Reports, 15-Day Alert Reports, IND SR including investigator letters and cover letters to regulatory authorities.

Woonsocket, Rhode Island, Us

•Helps health care providers and patients by greeting them in person and by phone; answering questions and requests; referring inquiries to the pharmacist.•Maintains records by recording and filing physicians' orders and prescriptions•Ensures medication availability by delivering medications to patients and departments.•Maintains pharmacy inventory by checking pharmaceutical stock to determine inventory level; anticipating needed medications and supplies; placing and expediting orders; verifying receipt; removing outdated drugs.•Process insurance claims

Raleigh, Nc, Us