•Interfaces between Company, sponsors, vendors, and other departments in the area of safety and pharmacovigilance; assists in the design and implementation of safety collection, processing, and reporting systems.
•Assumes responsibilities of safety project leader/endpoint manager for projects which require a team of Safety Specialists.
•Manages systems for receipt and tracking adverse event (AE)/endpoint information.
•Processes Adverse Events (AEs)/Endpoints according to Standard Operating Procedures (SOPs), and project specific safety plans.
•Generates reports to clients and regulatory authorities as needed.
•Assists in preparation and distribution of all required periodic reports for both clinical and post-marketing projects.
•Ensures that 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; ensures correct study setup and closure including proper documentation and archival.
•Assists training of Investigators and other departments on AE reporting/adjudication.
•Delivers presentations regarding safety and pharmacovigilance to internal and external customers.
•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.
Qualifications
Requirements:
•Bachelor Degree preferably in Business or Life Sciences or equivalent experience.
•Nominal years of Safety and PVG experience.
•Strong attention to details.
•Excellent time management skills to manage multiple workload.
•Bachelor Degree preferably in Business or Life Sciences or equivalent experience.
•Nominal years of Safety and PVG experience.
•Strong attention to details.
•Excellent time management skills to manage multiple workload.