Require Safety Specialist at Syneos Health
Post : Safety Specialist I
Performs all aspects of the collection, processing, and reporting of adverse events, adhering to all data protection guidelines, Health Insurance Portability and Accountability Act (HIPAA), Good Clinical Practices (GCPs), regulatory guidelines and study procedures. May progress to leading minimally complex studies.
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.
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.
Qualification : BA/BS in Life Science or Registered Nurse/Pharmacist
Location : Gurgaon – Cyber-City
Industry Type : Pharma
Functional Area : Safety & Pharmaco
End Date : 10th June, 2019
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