Drug Safety Associate Job in Raritan 08869, New Jersey US

Drug Safety Associate III

Responsible for participating in the collection, safety review, processing and reporting of adverse events data in compliance with applicable FDA and global regulations and Janssen AI Standard Operating Procedures (SOPs) and guidelines.

Major Duties and Responsibilities:

• Processes adverse event information received by the GPRM department for assigned products, and assists in the preparation of internal and external reports.
o Triages incoming cases to determine seriousness for processing and reporting prioritization
o Reviews case information for appropriate distribution to internal and external business partners
o Performs accurate computer data entry of identified AE information and ensures the uniform and timely processing and reporting of adverse event to Regulatory authorities.
o Reviews adverse event information received for completeness and consistency, and initiates in case follow-up processes/SAE query management, including phone calls to investigator sites, as needed.
o Writes case narratives independently
o Adheres to company templates and guidelines for documentation and communications.
o Performs quality control activities to ensure complete and accurate case information has been entered into the safety database.
• Coordinates the compilation of individual and aggregate reports per US and international regulations.
• May assist in coordinating the department's workflow and assist with special projects.
• Participates in the creation of GPRM policies and procedures and standard operating procedures.
• May act as a liaison with internal departments and external business partners on GPRM operations issues, contract process, and clinical study related activities.
• Ensure compliance with corporate and departmental SOPs.
• May distribute and track completed regulatory reports to Regulatory Affairs, Clinical Operations and other, as needed, to meet regulatory reporting timelines.
• May review, distribute and track reports to the Safety Management Committee as required.
• May mentor and train Drug Safety Coordinators and newly hired Drug Safety Associates.
• May serve as delegate for Sr Manager GRPM Operations as indicated.
• Performs other activities/projects as required.

Please respond by sending your resume to garima@ustechsolutions.com