1. Interfaces between Company, sponsors, vendors, and other departments in the area of safety and pharmacovigilance. 2. Processes Adverse Events (AEs)/Endpoints according to Standard Operating Procedures (SOPs) and project-specific safety plans. 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) Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases. 3. Assists safety project lead/endpoint manager in the preparation of a safety management plan. 4. Distributes all required periodic reports for both clinical and post-marketing projects. 5. 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. 6. 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. 7. Maintains understanding of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process. 8. Maintains knowledge of ongoing projects and disease-related terminology.
BA/BS in Life Science or Registered Nurse/Pharmacist. Nominal clinical/clinical research experience or equivalent combination of education and experience. Safety and Pharmacovigilance experience. Clinical Research Organization (CRO) experience with therapeutic specialties preferred. Knowledge of safety database preferred. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), e-mail, and internet. Some understanding and usage of medical terminology. 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.
Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.