INC Research is a company headquartered in the United States and that the personal information collected on its websites may be sent to, stored or processed in the United States or to any other country in which INC Research or its affiliates, subsidiaries or agents maintain facilities. While INC Research is committed to providing your voluntarily disclosed employment application information with a reasonable level of privacy protection, you should know that the general level of protection for personal information in the United States may not be the same as that provided in other countries. By using the INC Research website and/or providing INC Research with personal identifiable information, you fully understand and unambiguously consent to the transfer and the collection and processing of such information in the United States.
Post: Drug Safety Specialist I & II
• 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.
• 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.
• 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.
Candidate Profile :
•Bachelor Degree preferably in Business or Life Sciences or equivalent experience.
•Nominal years of Safety and PVG experience.
•Strong attention to details.
•Excellent time management skills to manage multiple workload.
Qualification: Bachelors Degree
Location: India - Gurgaon
Job ID: 17001974
"Industry Type: Pharma/ Biotech/Clinical Research
End Date: 20th May, 2017
See All B.Pharm Alerts M.Sc Alerts Mumbai Alerts
See All Other Jobs in our Database
PharmaTutor Magazine- Latest Issues