Sr Safety Specialist (United States)
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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 or oversee one or several projects of various levels of complexity. Manages daily workload of Safety Specialists within the department with limited line management
responsibilities. Mentors and trains junior Safety Specialists. Ensures that the project activities are completed in a timely manner with acceptable quality and acts as a decision maker. Supports business development activities and
* 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, including but not limited to: a) Assignment of resources and timelines; reorganization of daily workload based on priority b) Decision making for the project. c) Proactive communication to management new issues and suggested solutions; and reporting availability to take on new assignments. d) Development and review of project proposals, budgets, agreements, invoices, financial measures, and performance metrics. e) Preparation of a Safety Management Plan. f) Coordination of workload /workflow and coordination of status reviews. g) Review of project performance metrics (including quality parameters, monthly budget reports, and changes in scope). h) Approval of invoices.
* 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. a) Triages AEs; evaluates AE data for completeness, accuracy and regulatory reportability. b) Enters data into safety /adjudication database. c) Performs Quality Control (QC) of entered data/endpoint dossiers. d) Codes events, medical history, concomitant medications,and tests. e) Compiles complete narrative summaries. f) 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. g) 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. h) Assembles adjudication dossiers. i) Coordinates with data management staff reconciliation of safety data between the clinical and safety databases.
* Ensures that all aspects of the Company s safety data collection and processing are consistent with currentindustry 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.
* Provides input to senior departmental management regarding ways to ensure adherence to relevant procedures/regulations, ways to improve work efficiency and maintain customer satisfaction.
* 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. Moderate 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.