Safety Intelligence Specialist

5 days ago


Bengaluru, Karnataka, India beBeeSurveillance Full time ₹ 15,00,000 - ₹ 28,00,000
Job Description

As a Safety Surveillance Specialist, you will be responsible for maintaining the accuracy and compliance of safety data in the Company Core Data Sheet (CCDS) for development products. This includes reviewing labeling for marketed products and participating as a reviewer of change requests.

You will also prepare relevant sections of Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), and clinical Risk Management Plans (RMPs). Additionally, you will provide safety input to Product Development Plans (PDP), Trial Outlines, Protocols, Clinical Trial Reports, Investigator's Brochures (IB), integrated safety summaries, abstracts, and planned publications.

Another key responsibility is proactively communicating safety issues through participation in project/trial groups/teams and conducting Investigator training. You will also respond to inquiries from Health Authorities (HAs) and Ethics Committees (ECs) regarding safety aspects of protocols and Patient Information (PI)/Informed Consent (ICs).

Furthermore, you will establish and ensure deliverables to/from Data Monitoring Committees (DMCs).



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