•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; acts as a primary point of contact for information regarding assigned projects; represents Safety and Pharmacovigilance on cross functional teams.
•Assists with the workload of other Safety Specialists within the department.
•Liaises with Manager or designee with regard to resources, timelines, and issues with quality; reorganizes daily workload based on priority; proactively communicates to management new issues; offers solutions and reports availability to take on new assignments.
•Trains new staff; acts as the primary resource for other Safety Specialists with regards to answering questions, sharing knowledge and assisting in resolving problems; provides technical support.
•Mentors less experienced members of the team.
•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 AEs/endpoints according to Standard Operating Procedures (SOPs), and project specific safety plan.
•Generates reports to clients and regulatory authorities as needed.
•Distributes 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.
•Trains Investigators and other departments on AE reporting/adjudication.
•Delivers presentations regarding safety and pharmacovigilance to internal and external customers.
•Provides support to senior departmental management surrounding business development activities, budget, and proposal input, etc., as required.
•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.
•Bachelor Degree preferably in Business or Life Sciences or equivalent experience.
•Strong attention to details.
•Excellent time management skills to manage multiple workload.
Industry Type: Pharma
Requisition Code: 16005284
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