Post Marketing Safety Specialist II (Raleigh, NC)
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POST DATE 8/19/2016
END DATE 11/25/2016
Performs all aspects of the collection, processing, and reporting of adverse events/endpoints adhering to all data protection guidelines, Health Insurance Portability and Accountability Act (HIPAA), Good Clinical Practices (GCPs), regulatory guidelines and study procedures. May lead one or several projects of moderate to high complexity.
* 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, including but not limited to:
* Assigns resources and timelines; reorganizes daily workload based on priority.
* Proactively communicates to management new issues and suggested solutions; reports availability to take on new assignments.
* Develops and reviews project proposals, agreements, invoices, financial measures, and performance metrics; performs limited budget review under supervision.
* Prepares Safety Management Plan.
* Coordinates workload /workflow and status reviews.
* 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.
* 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.
* 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.
* Maintains understanding of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process.
* Maintains knowledge of ongoing projects and disease-related terminology.
Performs other work related duties as assigned. Minimal travel may be required.
BA/BS in Life Science or Registered Nurse/Pharmacist. Nominal experience in Safety and Pharmacovigilance or clinical/clinical research experience or equivalent combination of education and experience. Clinical Research Organization (CRO) experience with therapeutic specialties preferred. Knowledge of relevant international regulations/guidelines and strong understanding and usage of medical terminology preferred. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), e-mail, and internet. Strong organizational, presentation, documentation, analytical, oral/ written (English), and interpersonal skills with strong judgment and tactful discretion appropriate to a professional medical setting. Ability to make effective decisions, manage multiple priorities, exhibit high degree of accuracy, and meet deadlines in a highly dynamic environment. Ability to be flexible, adapt to change, work independently, as well as part of a team in a matrix environment.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.